Is Direct Rx FDA approved?

Direct Rx holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Direct Rx's registered sites?

The FDA register lists Dawsonville, GA. Registered operations: relabelling, repackaging.

What drugs does Direct Rx make?

554 products are listed under Direct Rx in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Direct Rx

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 554
Labeller names: 9
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Direct Rx	94 World Wide Drive Suite 110, Dawsonville, Georgia (GA) 30534, United States (USA)	Relabelling, Repackaging	3011690045079254320

Catalogue

Drug listings by form and route

554

554 active NDC listings: 554 human prescription drug. By marketing category: ANDA 525, NDA 13, UNAPPROVED DRUG OTHER 10, NDA AUTHORIZED GENERIC 6.

Dosage form	NDCs
tablet	224
tablet, film coated	116
capsule	83
tablet, extended release	31
cream	18
ointment	10
solution	9
capsule, delayed release	7
capsule, extended release	7
gel	6
powder, for suspension	6
tablet, coated	6
tablet, film coated, extended release	6
solution/ drops	5
tablet, delayed release	5

Route	NDCs
oral	495
topical	38
ophthalmic	8
sublingual	4
cutaneous	3
auricular (otic)	2
intramuscular	2
transdermal	2
intravenous	1
nasal	1

Labeller name on the listing	NDCs
direct_rx	314
direct rx	125
direct rx	39
direct rx	36
direct_rx	35
direct_rx	2
direct _rx	1
direct rx	1
direct_rx	1

Catalogue

Marketed products

554

Showing 150 of 554.

Brand	Generic name	Form / route	NDC
ACETAMINOPHEN AND CODEINE	ACETAMINOPHEN AND CODEINE	tablet, oral	61919-484ANDA
ALLOPURINOL	ALLOPURINOL	tablet, oral	72189-417ANDA
AMITRIPTYLINE HCL	AMITRIPTYLINE HCL	tablet, film coated, oral	72189-420ANDA
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	capsule, oral	72189-260ANDA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	tablet, oral	72189-162ANDA
AMOXICILLIN	AMOXICILLIN	powder, for suspension, oral	61919-401ANDA
ANASTROZOLE	ANASTROZOLE	tablet, oral	72189-415ANDA
ARMODAFINIL	ARMODAFINIL	tablet, oral	72189-133ANDA
ARMODAFINIL	ARMODAFINIL	tablet, oral	72189-261NDA AUTHORIZED GENERIC
ATENOLOL	ATENOLOL	tablet, oral	72189-135ANDA
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	tablet, film coated, oral	72189-226ANDA
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	tablet, oral	72189-239ANDA
AZITHROMYCIN	AZITHROMYCIN	tablet, film coated, oral	72189-015ANDA
AZITHROMYCIN	AZITHROMYCIN	tablet, film coated, oral	72189-087ANDA
AZITHROMYCIN	AZITHROMYCIN	tablet, film coated, oral	72189-088ANDA
AZITHROMYCIN	AZITHROMYCIN	tablet, film coated, oral	72189-093ANDA
AZITHROMYCIN DIHYDRATE	AZITHROMYCIN DIHYDRATE	tablet, film coated, oral	72189-089ANDA
AZITHROMYCIN DIHYDRATE	AZITHROMYCIN DIHYDRATE	tablet, film coated, oral	72189-090ANDA
Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	tablet, oral	72189-376ANDA
Acyclovir	Acyclovir	tablet, oral	72189-631ANDA
Allopurinol	Allopurinol	tablet, oral	72189-437ANDA
Allopurinol	Allopurinol	tablet, oral	72189-647ANDA
Alprazolam	Alprazolam	tablet, oral	72189-450ANDA
Alprazolam C-IV	Alprazolam C-IV	tablet, oral	72189-442ANDA
Alprazolam C-IV	Alprazolam C-IV	tablet, oral	72189-443ANDA
Alprazolam ODT C-IV	Alprazolam ODT C-IV	tablet, orally disintegrating, oral	72189-637ANDA
Amantadine HCL	Amantadine HCL	capsule, oral	72189-412ANDA
Amantadine HCL	Amantadine HCL	tablet, oral	72189-535ANDA
Amantadine HCL	Amantadine HCL	capsule, oral	72189-657ANDA
Amitriptyline HCL	Amitriptyline HCL	tablet, film coated, oral	72189-431ANDA
Amitriptyline HCL	Amitriptyline HCL	tablet, film coated, oral	72189-440ANDA
Amitriptyline HCL	Amitriptyline HCL	tablet, film coated, oral	72189-444ANDA
Amitriptyline HCL	Amitriptyline HCL	tablet, oral	72189-581ANDA
Amitriptyline HCL	Amitriptyline HCL	tablet, film coated, oral	72189-588ANDA
Amitriptyline HCL	Amitriptyline HCL	tablet, film coated, oral	72189-622ANDA
Amitza	Lubiprostone	capsule, gelatin coated, oral	72189-410ANDA
Amlodipine Besylate	Amlodipine Besylate	tablet, oral	72189-520ANDA
Amlodipine Besylate	Amlodipine Besylate	tablet, oral	72189-529ANDA
Amoxicillin	Amoxicillin	tablet, film coated, oral	72189-463ANDA
Amoxicillin/Clav Pot	Amoxicillin/Clav Pot	tablet, film coated, oral	72189-638ANDA
Amoxicillin/Clav Pot Oral Susp	Amoxicillin/Clav Pot Oral Susp	powder, for suspension, oral	72189-367ANDA
Anastrozole	Anastrozole	tablet, oral	72189-682ANDA
Aripiprazole	Aripiprazole	tablet, oral	72189-455ANDA
Aripiprazole	Aripiprazole	tablet, oral	72189-456ANDA
Aripiprazole	Aripiprazole	tablet, oral	72189-466ANDA
Aripiprazole	Aripiprazole	tablet, oral	72189-476ANDA
Armodafinil	Armodafinil	tablet, oral	72189-464ANDA
Atenolol	Atenolol	tablet, oral	72189-146ANDA
Atenolol	Atenolol	tablet, oral	72189-396ANDA
Atorvastatin Calcium	Atorvastatin Calcium	tablet, oral	72189-531ANDA
Atorvastatin Calcium	Atorvastatin Calcium	tablet, film coated, oral	72189-537ANDA
Atorvastatin Calcium	Atorvastatin Calcium	tablet, film coated, oral	72189-557ANDA
Atorvastatin Calcium	Atorvastatin Calcium	tablet, film coated, oral	72189-587ANDA
Atorvastatin Calcium	Atorvastatin Calcium	tablet, film coated, oral	72189-681ANDA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	tablet, coated, oral	72189-110ANDA
BENZONATATE	BENZONATATE	capsule, oral	61919-400ANDA
BENZONATATE	BENZONATATE	capsule, oral	72189-192ANDA
BENZONATATE	BENZONATATE	capsule, oral	72189-194ANDA
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	tablet, oral	61919-128ANDA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	tablet, extended release, oral	72189-057ANDA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	tablet, extended release, oral	72189-124ANDA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	tablet, extended release, oral	72189-134ANDA
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	tablet, oral	61919-166ANDA
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	tablet, oral	72189-175ANDA
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	tablet, oral	72189-200ANDA
BUTAL/APAP/CAFFEINE	BUTAL/APAP/CAFFEINE	tablet, oral	72189-600ANDA
Baclofen	Baclofen	tablet, oral	72189-504ANDA
Baclofen	Baclofen	tablet, oral	72189-565ANDA
Benzonatate	Benzonatate	capsule, oral	72189-606ANDA
Buprenorphine Sublingual	Buprenorphine Sublingual	tablet, sublingual	72189-579ANDA
Buprenorphine Sublingual C-III	Buprenorphine Sublingual C-III	tablet, sublingual	72189-580ANDA
Buprenorphine Sublingual C-III	Buprenorphine Sublingual C-III	tablet, sublingual	72189-582ANDA
Bupropion HCL	Bupropion HCL	tablet, film coated, oral	72189-457ANDA
Bupropion HCL ER (XL)	Bupropion HCL ER (XL)	tablet, extended release, oral	61919-558ANDA
Bupropion HCL ER (XL)	Bupropion HCL ER (XL)	tablet, extended release, oral	72189-539ANDA
Buspirone HCL	Buspirone HCL	tablet, oral	72189-448ANDA
Buspirone HCL	Buspirone HCL	tablet, oral	72189-458ANDA
Buspirone HCL	Buspirone HCL	tablet, oral	72189-620ANDA
Buspirone HCL	Buspirone HCL	tablet, oral	72189-628ANDA
Buspirone Hcl	Buspirone Hcl	tablet, oral	72189-235ANDA
Butal/APAP/Caff	Butal/APAP/Caff	tablet, oral	72189-441ANDA
CARBAMAZEPINE	CARBAMAZEPINE	tablet, oral	72189-157ANDA
CEFADROXIL	CEFADROXIL	capsule, oral	72189-103ANDA
CEFDINIR	CEFDINIR	powder, for suspension, oral	72189-043ANDA
CEFDINIR	CEFDINIR	powder, for suspension, oral	72189-185ANDA
CEFDINIR	CEFDINIR	powder, for suspension, oral	72189-186ANDA
CEFDINIR	CEFDINIR	powder, for suspension, oral	72189-259ANDA
CELECOXIB	CELECOXIB	capsule, oral	72189-123ANDA
CEPHALEXIN	CEPHALEXIN	capsule, oral	61919-606ANDA
CILOSTAZOL	CILOSTAZOL	tablet, oral	72189-116ANDA
CIPROFLOXACIN	ciprofloxacin hydrochloride	tablet, film coated, oral	72189-111ANDA
CIPROFLOXACIN	CIPROFLOXACIN	tablet, coated, oral	72189-323ANDA
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	capsule, oral	72189-189ANDA
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	cream, topical	72189-262ANDA
CLONAZEPAM	CLONAZEPAM	tablet, oral	72189-081ANDA
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	cream, topical	72189-182ANDA
COLCHICINE	COLCHICINE	tablet, film coated, oral	72189-249NDA
COLCHICINE	COLCHICINE	tablet, oral	72189-331ANDA
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	tablet, film coated, oral	61919-261ANDA
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	tablet, film coated, oral	72189-080ANDA
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	capsule, extended release, oral	72189-101ANDA
Carisoprodol	Carisoprodol	tablet, oral	61919-878ANDA
Carisoprodol	Carisoprodol	tablet, oral	72189-386ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	72189-372ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	72189-653ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	72189-663ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	72189-664ANDA
Cefadroxil	Cefadroxil	capsule, oral	72189-445ANDA
Cefadroxil	Cefadroxil	capsule, oral	72189-506ANDA
Cefazolin Sodium	Cefazolin Sodium	injection, powder, for solution, intramuscular, intravenous	72189-584ANDA
Cefdinir	Cefdinir	capsule, oral	72189-423ANDA
Celecoxib	Celecoxib	capsule, oral	72189-662ANDA
Celecoxib	Celecoxib	capsule, oral	72189-685ANDA
Chlorthalidone	Chlorthalidone	tablet, oral	72189-356ANDA
Chlorthalidone	Chlorthalidone	tablet, oral	72189-507ANDA
Chlorthalidone	Chlorthalidone	tablet, oral	72189-644ANDA
Ciprofloxacin	Ciprofloxacin	tablet, oral	72189-616ANDA
Ciprofloxacin	Ciprofloxacin	tablet, oral	72189-623ANDA
Ciprofloxacin	Ciprofloxacin	tablet, film coated, oral	72189-627ANDA
Clarithromycin	Clarithromycin	tablet, film coated, oral	72189-639ANDA
Clonazepam	Clonazepam	tablet, oral	72189-475ANDA
Clotrimazole/Betameth	Clotrimazole/Betameth	cream, topical	72189-518ANDA
Colchicine	Colchicine	tablet, film coated, oral	72189-687ANDA
Cyclobenzaprine HCL	Cyclobenzaprine HCL	tablet, film coated, oral	72189-680ANDA
Cyclobenzaprine HCL ER	Cyclobenzaprine HCL ER	capsule, extended release, oral	72189-362NDA
Cyclobenzaprine HCL ER	Cyclobenzaprine HCL ER	capsule, extended release, oral	72189-389NDA AUTHORIZED GENERIC
Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	tablet, film coated, oral	72189-545ANDA
DESVENLAFAXINE ER	DESVENLAFAXINE ER	tablet, film coated, extended release, oral	61919-882ANDA
DEXAMETHASONE	DEXAMETHASONE	tablet, oral	61919-827ANDA
DEXAMETHASONE	DEXAMETHASONE	tablet, oral	72189-254ANDA
DIAZEPAM	DIAZEPAM	tablet, oral	61919-409ANDA
DIAZEPAM	DIAZEPAM	tablet, oral	61919-906ANDA
DICLOFENAC SODIUM	DICLOFENAC SODIUM	gel, topical	72189-040ANDA
DICLOFENAC SODIUM	DICLOFENAC SODIUM	solution, topical	72189-075ANDA
DICLOFENAC SODIUM	DICLOFENAC SODIUM	solution, topical	72189-273ANDA
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE	capsule, extended release, oral	72189-248NDA AUTHORIZED GENERIC
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	tablet, oral	72189-336ANDA
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	tablet, film coated, oral	72189-031ANDA
DOXAZOSIN	DOXAZOSIN	tablet, oral	72189-117ANDA
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	capsule, oral	72189-161ANDA
DOXYCYCLINE	DOXYCYCLINE	capsule, oral	61919-276ANDA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	capsule, oral	61919-082ANDA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	tablet, film coated, oral	72189-127ANDA
DOXYCYCLINE MONOHYDRATE	DOXYCYCLINE MONOHYDRATE	capsule, oral	61919-624ANDA
Desipramine HCL	Desipramine HCL	tablet, oral	72189-391ANDA
Desvenlafaxine ER	Desvenlafaxine ER	tablet, extended release, oral	72189-567ANDA
Dexamethasone	Dexamethasone	tablet, oral	72189-383ANDA
Dexamethasone	Dexamethasone	tablet, oral	72189-468ANDA
Dexamethasone	Dexamethasone	tablet, oral	72189-511ANDA
Dexamethasone	Dexamethasone	tablet, oral	72189-523ANDA

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Enquiry

Common questions

Is Direct Rx FDA approved?: Direct Rx holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Direct Rx's registered sites?: The FDA register lists Dawsonville, GA. Registered operations: relabelling, repackaging.
What drugs does Direct Rx make?: 554 products are listed under Direct Rx in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule. 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.