Is Merck Sharp & Dohme Corp. FDA approved?

Merck Sharp & Dohme Corp. holds no registered establishment of its own; 121 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Merck Sharp & Dohme Corp. make?

121 products are listed under Merck Sharp & Dohme Corp. in the openFDA NDC Directory, most often as tablet, film coated; injection, suspension; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Merck Sharp & Dohme Corp.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 121
Labeller names: 4
Live patents: 144
Exclusivities: 9
Shortage listings: 5
Countries: 0

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Imipenem Anhydrous, Cilastatin, and Relebactam Anhydrous InjectionAnti-Infective	RECARBRIO, Injection, 500 mg/100 mL; 500 mg/100 mL; 250 mg/100 mL (NDC 0006-3856-02)	To Be Discontinued	-	9 Sept 20269 Sept 2026
Aprepitant Oral Powder for SuspensionGastroenterology	Emend, Oral Powder for Suspension, 125 mg (NDC 0006-3066-03)	To Be Discontinued	-	8 Apr 20268 Apr 2026
Imipenem and Cilastatin InjectionAnti-Infective	Primaxin, Injection, 500mg (NDC 0006-3516-59)	To Be Discontinued	-	8 Jan 20268 Jan 2026
Posaconazole InjectionAnti-Infective	Noxafil, Injection, 18 mg/1 mL (NDC 0085-4331-01)	To Be Discontinued	-	2 Dec 20252 Dec 2025
Elbasvir; Grazoprevir TabletAntiviral	Zepatier, Tablet, 50 mg; 100 mg (NDC 0006-3074-02)	To Be Discontinued	-	17 Oct 202517 Oct 2025

Catalogue

Drug listings by form and route

121

121 active NDC listings: 82 human prescription drug, 27 vaccine, 5 drug for further processing, 4 bulk ingredient, 2 licensed vaccine bulk intermediate, 1 plasma derivative. By marketing category: NDA 72, BLA 38, EXPORT ONLY 6, DRUG FOR FURTHER PROCESSING 5.

Dosage form	NDCs
tablet, film coated	36
injection, suspension	15
injection, solution	13
capsule	10
injection, powder, lyophilized, for solution	9
kit	6
injection, powder, for solution	3
injection, powder, lyophilized, for suspension	3
powder	3
powder, for suspension	3
solution	3
tablet, film coated, extended release	3
granule, for suspension	2
injection	2
liquid	2

Route	NDCs
oral	58
intramuscular	25
intravenous	16
subcutaneous	14
intravesical	1
percutaneous	1
respiratory (inhalation)	1

Labeller name on the listing	NDCs
merck sharp & dohme llc	110
merck sharp & dohme corp.	6
merck sharp & dohme llc.	4
merck sharp & dohme llc	1

Exclusivity

Patents and exclusivities

144

Patent	Product	Covers	Expiry
7326708*PED	JANUMET, JANUMET XR, JANUVIA, JUVISYNC, STEGLUJANertugliflozin; sitagliptin phosphate; metformin hydrochloride; sitagliptin phosphate; simvastatin; sitagliptin phosphate; sitagliptin phosphate	use	Oct 2026
7326708	JANUMET, JANUMET XR, JANUVIA, STEGLUJANertugliflozin; sitagliptin phosphate; metformin hydrochloride; sitagliptin phosphate; sitagliptin phosphate	substance, product	Nov 2026
7456219	ZOLINZAvorinostat	substance	Mar 2027
8119602	VICTRELISboceprevir	use	Mar 2027
7339053	IDVYNSOdoravirine; islatravir	substance	May 2027
8258132	EMENDaprepitant	product	Sept 2027
7772178	VICTRELISboceprevir	product	Nov 2027
8852632	ISENTRESSraltegravir potassium	substance, product	Jan 2028
8450372	ZOLINZAvorinostat	use	Mar 2028
8414921	JANUMETmetformin hydrochloride; sitagliptin phosphate	product	Jul 2028
RE46791	PREVYMISletermovir	substance, product	Jan 2029
8414921*PED	JANUMETmetformin hydrochloride; sitagliptin phosphate	use	Jan 2029
7754731	DUTREBIS, ISENTRESS, ISENTRESS HDlamivudine; raltegravir potassium; raltegravir potassium	substance, product	Mar 2029
10117951	NOXAFILposaconazole	product	Mar 2029
8410077	NOXAFILposaconazole	product	Mar 2029
9750822	NOXAFILposaconazole	product	Mar 2029
7973040	ZEPATIERelbasvir; grazoprevir	substance, product	Jul 2029
7754731*PED	DUTREBIS, ISENTRESS, ISENTRESS HDlamivudine; raltegravir potassium; raltegravir potassium	use	Sept 2029
7951797	BELSOMRAsuvorexant	substance, product	Nov 2029
8771733	ISENTRESS, ISENTRESS HDraltegravir potassium	substance, product	Jun 2030
9308204	SEGLUROMET, STEGLUJANertugliflozin; metformin hydrochloride; ertugliflozin; sitagliptin phosphate	product	Oct 2030
9439901	STEGLUJANertugliflozin; sitagliptin phosphate	use	Oct 2030
9439902	SEGLUROMETertugliflozin; metformin hydrochloride	use	Oct 2030
9649311	ISENTRESS HDraltegravir potassium	product	Oct 2030
9649311*PED	ISENTRESS HDraltegravir potassium	use	Apr 2031
8871759	ZEPATIERelbasvir; grazoprevir	substance, product	May 2031
10736896	VERQUVOvericiguat	substance, product	May 2031
11439642	VERQUVOvericiguat	use	May 2031
8420656	VERQUVOvericiguat	substance, product	May 2031
8921377	VERQUVOvericiguat	use	May 2031
9993476	VERQUVOvericiguat	use	May 2031
9358297	NOXAFILposaconazole	product	Jun 2031
9023790	NOXAFILposaconazole	product	Jul 2031
9062047	OHTUVAYREensifentrine	substance	Aug 2031
8080580	SEGLUROMET, STEGLATRO, STEGLUJANertugliflozin; ertugliflozin; metformin hydrochloride; ertugliflozin; sitagliptin phosphate	substance, product	Dec 2031
10772888	ISENTRESS HDraltegravir potassium	use	Mar 2032
8486975	DELSTRIGO, IDVYNSO, PIFELTROdoravirine; doravirine; islatravir; doravirine; lamivudine; tenofovir disoproxil fumarate	substance, product	Aug 2032
9604948	VERQUVOvericiguat	substance, product	Nov 2032
9493582	NOXAFILposaconazole	product	Feb 2033
10603384	PREVYMISletermovir	product	Feb 2033
8487093	RECARBRIOcilastatin sodium; imipenem; relebactam	substance, product	Mar 2033
10098892	BELSOMRAsuvorexant	product	May 2033
11980623	BELSOMRAsuvorexant	product	May 2033
12599610	BELSOMRAsuvorexant	product	May 2033
9908845	WELIREGbelzutifan	substance, product	Sept 2034
RE49948	WELIREGbelzutifan	substance, product	Sept 2034
10945950	OHTUVAYREensifentrine	product	Sept 2035
9956171	OHTUVAYREensifentrine	product	Sept 2035
10335388	WELIREGbelzutifan	use	Apr 2036
10603282	DELSTRIGOdoravirine; lamivudine; tenofovir disoproxil fumarate	product	Nov 2036
10842751	DELSTRIGOdoravirine; lamivudine; tenofovir disoproxil fumarate	product	Nov 2036
11427616	LIPFENDRAenlicitide decanoate	substance, product	Feb 2040
12358870	WELIREGbelzutifan	product	Jun 2042
12409180	OHTUVAYREensifentrine	product	Feb 2043
12251384	OHTUVAYREensifentrine	product	Jun 2044

Product	Exclusivity	Until
BRIDIONSUGAMMADEX SODIUM	PED Paediatric	Jun 2028
IDVYNSODORAVIRINE; ISLATRAVIR	NCE New chemical entity	Apr 2031
LIPFENDRAENLICITIDE DECANOATE	NCE New chemical entity	Jul 2031
NOXAFILPOSACONAZOLE	NPP New patient population	Jan 2029
OHTUVAYREENSIFENTRINE	NCE New chemical entity	Jun 2029
PREVYMISLETERMOVIR	ODE-495 Orphan drug	Aug 2031
RECARBRIOCILASTATIN SODIUM; IMIPENEM; RELEBACTAM	GAIN Qualified infectious disease product (GAIN)	Jul 2029
VERQUVOVERICIGUAT	D-198 New dosing schedule	Jan 2029
WELIREGBELZUTIFAN	I-994 New indication	Jun 2029

Catalogue

Marketed products

121

Brand	Generic name	Form / route	NDC
ANTIVENIN	Latrodectus mactans	kit	0006-5424BLA
BCG VACCINE	BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN	injection, powder, lyophilized, for solution, percutaneous	0052-0603BLA
BELSOMRA	suvorexant	tablet, film coated, oral	0006-0005NDA
BELSOMRA	suvorexant	tablet, film coated, oral	0006-0033NDA
BELSOMRA	suvorexant	tablet, film coated, oral	0006-0325NDA
BELSOMRA	suvorexant	tablet, film coated, oral	0006-0335NDA
BRIDION	sugammadex	injection, solution, intravenous	0006-5423NDA
BRIDION	sugammadex	injection, solution, intravenous	0006-5425NDA
CANCIDAS	CASPOFUNGIN ACETATE	injection, powder, lyophilized, for solution, intravenous	0006-3822NDA
CANCIDAS	CASPOFUNGIN ACETATE	injection, powder, lyophilized, for solution, intravenous	0006-3823NDA
CAPVAXIVE	Pneumococcal 21-valent Conjugate Vaccine	injection, solution, intramuscular	0006-4347BLA
-	CASPOFUNGIN ACETATE	injection, powder, lyophilized, for solution	69806-0092EXPORT ONLY
-	CILASTATIN SODIUM	powder	69806-0094EXPORT ONLY
DELSTRIGO	doravirine, lamivudine, and tenofovir disoproxil fumarate	tablet, film coated, oral	0006-5007NDA
DIFICID	FIDAXOMICIN	granule, for suspension, oral	52015-700NDA
Dificid	fidaxomicin	tablet, film coated, oral	52015-080NDA
EMEND	aprepitant	capsule, oral	0006-0461NDA
EMEND	aprepitant	capsule, oral	0006-0462NDA
EMEND	aprepitant	capsule, oral	0006-0464NDA
EMEND	FOSAPREPITANT DIMEGLUMINE	injection, powder, lyophilized, for solution, intravenous	0006-3061NDA
EMEND	aprepitant	powder, for suspension, oral	0006-3066NDA
EMEND	aprepitant	kit	0006-3862NDA
ENFLONSIA	CLESROVIMAB	injection, solution, intramuscular	0006-5073BLA
ERVEBO	ZAIRE EBOLAVIRUS (STRAIN KIKWIT-95) ENVELOPE GLYCOPROTEIN	injection, solution, intramuscular	0006-4293BLA
-	Ertapenem Sodium	powder	69806-0003EXPORT ONLY
GARDASIL	Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant	injection, suspension, intramuscular	0006-4045BLA
GARDASIL	Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant	injection, suspension, intramuscular	0006-4109BLA
GARDASIL 9	Human Papillomavirus 9-valent Vaccine, Recombinant	injection, suspension, intramuscular	0006-4119BLA
GARDASIL 9	Human Papillomavirus 9-valent Vaccine, Recombinant	injection, suspension, intramuscular	0006-4121BLA
-	HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN	liquid	69806-0001EXPORT ONLY
-	HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN	liquid	69806-0002EXPORT ONLY
IDVYNSO	Doravirine, Islatravir	tablet, film coated, oral	0006-5092NDA
-	IMIPENEM	powder	69806-0093EXPORT ONLY
-	IMIPENEM ANHYDROUS, cilastatin, and RELEBACTAM ANHYDROUS	injection, powder, for solution	0006-0138DRUG FOR FURTHER PROCESSING
INVANZ	ertapenem sodium	injection, powder, lyophilized, for solution, intramuscular, intravenous	0006-3843NDA
ISENTRESS	RALTEGRAVIR	tablet, film coated, oral	0006-0227NDA
ISENTRESS	RALTEGRAVIR	tablet, chewable, oral	0006-0473NDA
ISENTRESS	RALTEGRAVIR	tablet, chewable, oral	0006-0477NDA
ISENTRESS	RALTEGRAVIR	tablet, film coated, oral	0006-3080NDA
ISENTRESS	RALTEGRAVIR	granule, for suspension, oral	0006-3603NDA
JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	tablet, film coated, oral	0006-0575NDA
JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE	tablet, film coated, oral	0006-0577NDA
JANUMET XR	sitagliptin and metformin hydrochloride	tablet, film coated, extended release, oral	0006-0078NDA
JANUMET XR	sitagliptin and metformin hydrochloride	tablet, film coated, extended release, oral	0006-0080NDA
JANUMET XR	sitagliptin and metformin hydrochloride	tablet, film coated, extended release, oral	0006-0081NDA
JANUVIA	sitagliptin	tablet, film coated, oral	0006-0112NDA
JANUVIA	sitagliptin	tablet, film coated, oral	0006-0221NDA
JANUVIA	sitagliptin	tablet, film coated, oral	0006-0277NDA
KEYTRUDA	pembrolizumab	injection, solution, intravenous	0006-3026BLA
KEYTRUDA QLEX	pembrolizumab and berahyaluronidase alfa-pmph	injection, solution, subcutaneous	0006-3083BLA
KEYTRUDA QLEX	pembrolizumab and berahyaluronidase alfa-pmph	injection, solution, subcutaneous	0006-5083BLA
LIPFENDRA	LIPFENDRA	tablet, film coated, oral	0006-5084NDA
M-M-R II	measles, mumps, and rubella virus vaccine live	injection, powder, lyophilized, for suspension, intramuscular, subcutaneous	0006-4681BLA
NOXAFIL	posaconazole	suspension, oral	0085-1328NDA
NOXAFIL	posaconazole	powder, for suspension, oral	0085-2224NDA
NOXAFIL	posaconazole	tablet, coated, oral	0085-4324NDA
NOXAFIL	posaconazole	solution, intravenous	0085-4331NDA
Ohtuvayre	ensifentrine	suspension, respiratory (inhalation)	83034-003NDA
PIFELTRO	doravirine	tablet, film coated, oral	0006-3069NDA
PNEUMOVAX 23	pneumococcal vaccine polyvalent	injection, solution, intramuscular, subcutaneous	0006-4837BLA
PNEUMOVAX 23	pneumococcal vaccine polyvalent	injection, solution, intramuscular, subcutaneous	0006-4943BLA
PREVYMIS	LETERMOVIR	tablet, film coated, oral	0006-3075NDA
PREVYMIS	LETERMOVIR	tablet, film coated, oral	0006-3076NDA
PREVYMIS	LETERMOVIR	injection, solution, intravenous	0006-5003NDA
PREVYMIS	LETERMOVIR	injection, solution, intravenous	0006-5004NDA
PREVYMIS	LETERMOVIR	pellet, oral	0006-5085NDA
PREVYMIS	LETERMOVIR	pellet, oral	0006-5086NDA
PRIMAXIN IV	imipenem and cilastatin sodium	injection, powder, for solution, intravenous	0006-3516NDA
PedvaxHIB	Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)	injection, suspension, intramuscular	0006-4897BLA
ProQuad	Measles, Mumps, Rubella and Varicella Virus Vaccine Live	injection, powder, lyophilized, for suspension, intramuscular, subcutaneous	0006-4171BLA
RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	injection, powder, for solution, intravenous	0006-3856NDA
RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)	injection, suspension, intramuscular, subcutaneous	0006-4093BLA
RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)	injection, suspension, intramuscular, subcutaneous	0006-4094BLA
RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)	injection, suspension, intramuscular, subcutaneous	0006-4981BLA
RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)	injection, suspension, intramuscular, subcutaneous	0006-4992BLA
RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)	injection, suspension, intramuscular, subcutaneous	0006-4995BLA
RotaTeq	Rotavirus Vaccine, Live, Oral, Pentavalent	solution, oral	0006-4047BLA
RotaTeq	Rotavirus Vaccine, Live, Oral, Pentavalent	solution, oral	0006-4379BLA
SEGLUROMET	ertugliflozin and metformin hydrochloride	tablet, film coated, oral	0006-5369NDA
SEGLUROMET	ertugliflozin and metformin hydrochloride	tablet, film coated, oral	0006-5370NDA
SEGLUROMET	ertugliflozin and metformin hydrochloride	tablet, film coated, oral	0006-5373NDA
SEGLUROMET	ertugliflozin and metformin hydrochloride	tablet, film coated, oral	0006-5374NDA
SIVEXTRO	tedizolid phosphate	injection, powder, lyophilized, for solution, intravenous	67919-040NDA
SIVEXTRO	tedizolid phosphate	tablet, film coated, oral	67919-041NDA
STEGLATRO	ertugliflozin	tablet, film coated, oral	0006-5363NDA
STEGLATRO	ertugliflozin	tablet, film coated, oral	0006-5364NDA
STEGLUJAN	ertugliflozin and sitagliptin	tablet, film coated, oral	0006-5367NDA
STEGLUJAN	ertugliflozin and sitagliptin	tablet, film coated, oral	0006-5368NDA
STERILE DILUENT	Sterile Water	injection, intramuscular, subcutaneous	0006-4175BLA
STERILE DILUENT	Sterile Water	injection, intramuscular, subcutaneous	0006-4309BLA
STROMECTOL	ivermectin	tablet, oral	0006-0032NDA
TEMODAR	Temozolomide	capsule, oral	0085-1366NDA
TEMODAR	Temozolomide	injection, powder, lyophilized, for solution, intravenous	0085-1381NDA
TEMODAR	Temozolomide	capsule, oral	0085-1417NDA
TEMODAR	Temozolomide	capsule, oral	0085-1425NDA
TEMODAR	Temozolomide	capsule, oral	0085-1430NDA
TEMODAR	Temozolomide	capsule, oral	0085-1519NDA
TEMODAR	Temozolomide	capsule, oral	0085-3004NDA
TICE BCG	BACILLUS CALMETTE-GUERIN	powder, for suspension, intravesical	0052-0602BLA
VAQTA	hepatitis A vaccine, inactivated	injection, suspension, intramuscular	0006-4095BLA
VAQTA	hepatitis A vaccine, inactivated	injection, suspension, intramuscular	0006-4096BLA
VAQTA	hepatitis A vaccine, inactivated	injection, suspension, intramuscular	0006-4831BLA
VAQTA	hepatitis A vaccine, inactivated	injection, suspension, intramuscular	0006-4841BLA
VARIVAX	Varicella Virus Vaccine Live	injection, powder, lyophilized, for suspension, subcutaneous	0006-4827BLA
VAXNEUVANCE	Pneumococcal 15-valent Conjugate Vaccine CRM197 Protein adsorbed	injection, suspension, intramuscular	0006-4329BLA
VERQUVO	vericiguat	tablet, film coated, oral	0006-5028NDA
VERQUVO	vericiguat	tablet, film coated, oral	0006-5029NDA
VERQUVO	vericiguat	tablet, film coated, oral	0006-5030NDA
WELIREG	belzutifan	tablet, film coated, oral	0006-5331NDA
WINREVAIR	SOTATERCEPT-CSRK	kit	0006-5087BLA
WINREVAIR	SOTATERCEPT-CSRK	kit	0006-5088BLA
WINREVAIR	SOTATERCEPT-CSRK	kit	0006-5090BLA
WINREVAIR	SOTATERCEPT-CSRK	kit	0006-5091BLA
ZEPATIER	elbasvir and grazoprevir	tablet, film coated, oral	0006-3074NDA
ZERBAXA	ceftolozane and tazobactam	injection, powder, lyophilized, for solution, intravenous	67919-030NDA
ZINPLAVA	bezlotoxumab	injection, solution, intravenous	0006-3025BLA
ZOLINZA	vorinostat	capsule, oral	0006-0568NDA
-	suvorexant	tablet, film coated	0006-0001DRUG FOR FURTHER PROCESSING
-	suvorexant	tablet, film coated	0006-0002DRUG FOR FURTHER PROCESSING
-	suvorexant	tablet, film coated	0006-0003DRUG FOR FURTHER PROCESSING
-	suvorexant	tablet, film coated	0006-0004DRUG FOR FURTHER PROCESSING

Enquiry

Common questions

Is Merck Sharp & Dohme Corp. FDA approved?: Merck Sharp & Dohme Corp. holds no registered establishment of its own; 121 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Merck Sharp & Dohme Corp. make?: 121 products are listed under Merck Sharp & Dohme Corp. in the openFDA NDC Directory, most often as tablet, film coated; injection, suspension; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.