Is PAI Holdings, LLC FDA approved?

PAI Holdings, LLC 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 PAI Holdings, LLC's drugs manufactured?

The FDA register lists Greenville, SC. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.

What drugs does PAI Holdings, LLC make?

146 products are listed under PAI Holdings, LLC in the openFDA NDC Directory, most often as solution; suspension; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

PAI Holdings, LLC

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

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Registered sites: 1
Active NDC listings: 145
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaRegistrant: PAI Holdings, LLC	1700 Perimeter Road, Greenville, South Carolina (SC) 29605, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	1017687044940096

Catalogue

Drug listings by form and route

145

145 active NDC listings: 105 human prescription drug, 40 human otc drug. By marketing category: ANDA 97, OTC MONOGRAPH DRUG 36, NDA 6, UNAPPROVED DRUG OTHER 5, NDA AUTHORIZED GENERIC 1.

Dosage form	NDCs
solution	88
suspension	26
liquid	5
tablet	4
injection	3
injection, powder, for solution	3
capsule	2
powder, for solution	2
rinse	2
syrup	2
elixir	1
inhalant	1
injection, powder, lyophilized, for solution	1
injection, solution	1
kit	1

Route	NDCs
oral	127
intravenous	7
intramuscular	5
sublingual	4
topical	4
respiratory (inhalation)	1
subcutaneous	1

Labeller name on the listing	NDCs
pai holdings, llc dba pai pharma	141
pai holdings, llc	4

Catalogue

Marketed products

146

Showing 145 of 146.

Brand	Generic name	Form / route	NDC
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	solution, oral	0121-0646ANDA
Acetaminophen	Acetaminophen	solution, oral	0121-0657OTC MONOGRAPH DRUG
Acetaminophen	Acetaminophen	suspension, oral	0121-0941OTC MONOGRAPH DRUG
Acetaminophen	Acetaminophen	solution, oral	0121-1047OTC MONOGRAPH DRUG
Acetaminophen	Acetaminophen	solution, oral	0121-1314OTC MONOGRAPH DRUG
Acetaminophen	Acetaminophen	suspension, oral	0121-1882OTC MONOGRAPH DRUG
Acetaminophen	Acetaminophen	solution, oral	0121-1971OTC MONOGRAPH DRUG
Acetaminophen	Acetaminophen	solution, oral	0121-2094OTC MONOGRAPH DRUG
Acetaminophen	Acetaminophen	suspension, oral	0121-2823OTC MONOGRAPH DRUG
Acetaminophen	Acetaminophen	solution, oral	0121-3141OTC MONOGRAPH DRUG
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	solution, oral	0121-0504ANDA
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN and CODEINE PHOSPHATE	solution, oral	0121-1008ANDA
Atovaquone	Atovaquone	suspension, oral	0121-0956ANDA
Atovaquone	Atovaquone	suspension, oral	0121-1016ANDA
Benzocaine 20%	Benzocaine 20%	solution, topical	0121-1077OTC MONOGRAPH DRUG
Brivaracetam	Brivaracetam	solution, oral	0121-1074ANDA
Brivaracetam	Brivaracetam Injection	injection, intravenous	0121-1075ANDA
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	solution, oral	0121-0933ANDA
Buprenorphine and Naloxone	buprenorphine hydrochloride and naloxone hydrochloride	tablet, sublingual	0121-1018ANDA
Buprenorphine and Naloxone	buprenorphine hydrochloride and naloxone hydrochloride	tablet, sublingual	0121-2036ANDA
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	rinse, oral	0121-0893ANDA
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	rinse, oral	0121-1786ANDA
Calcium Carbonate	Calcium Carbonate	suspension, oral	0121-0766OTC MONOGRAPH DRUG
Calcium Carbonate	Calcium Carbonate	suspension, oral	0121-4766OTC MONOGRAPH DRUG
Cefotan	Cefotetan	injection, powder, for solution, intramuscular, intravenous	0121-0976NDA
Cefotan	Cefotetan	injection, powder, for solution, intramuscular, intravenous	0121-0977NDA
Cetirizine Hydrochloride	Cetirizine Hydrochloride	solution, oral	0121-0874ANDA
Childrens Acetaminophen	Acetaminophen	suspension, oral	0121-1781OTC MONOGRAPH DRUG
Childrens Ibuprofen Oral Suspension	Ibuprofen	suspension, oral	0121-0833ANDA
Childrens Ibuprofen Oral Suspension	Ibuprofen	suspension, oral	0121-1666ANDA
Childrens Simethicone Drops	Childrens Simethicone Drops	liquid, oral	0121-1095OTC MONOGRAPH DRUG
Cimetidine Hydrochloride	Cimetidine Hydrochloride	solution, oral	0121-1025ANDA
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	solution, oral	0121-0489ANDA
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	solution, oral	0121-0978ANDA
Diphenhydramine HCl	diphenhydramine hydrochloride	solution, oral	0121-0865OTC MONOGRAPH DRUG
Diphenhydramine HCl	diphenhydramine hydrochloride	solution, oral	0121-1730OTC MONOGRAPH DRUG
Docusate Sodium	Docusate Sodium	liquid, oral	0121-0935OTC MONOGRAPH DRUG
Docusate Sodium	Docusate Sodium	liquid, oral	0121-1870OTC MONOGRAPH DRUG
Dye Free Childrens Acetaminophen	Acetaminophen	suspension, oral	0121-0966OTC MONOGRAPH DRUG
Dye Free Childrens Ibuprofen	Ibuprofen	suspension, oral	0121-1022ANDA
Dye Free Childrens Ibuprofen	Ibuprofen	suspension, oral	0121-2044ANDA
ETHOSUXIMIDE	ETHOSUXIMIDE	solution, oral	0121-0670ANDA
Fluoxetine	FLUOXETINE HYDROCHLORIDE	solution, oral	0121-0721ANDA
Fluoxetine	FLUOXETINE HYDROCHLORIDE	solution, oral	0121-4721ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	solution, concentrate, oral	0121-0653ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	elixir, oral	0121-0654ANDA
GUAIFENESIN	GUAIFENESIN	solution, oral	0121-0744OTC MONOGRAPH DRUG
GUAIFENESIN	GUAIFENESIN	solution, oral	0121-1488OTC MONOGRAPH DRUG
GUAIFENESIN	GUAIFENESIN	solution, oral	0121-1744OTC MONOGRAPH DRUG
GUAIFENESIN	GUAIFENESIN	solution, oral	0121-2232OTC MONOGRAPH DRUG
GUAIFENESIN DM	GUAIFENESIN and DEXTROMETHORPHAN	syrup, oral	0121-0638OTC MONOGRAPH DRUG
GUAIFENESIN DM	GUAIFENESIN and DEXTROMETHORPHAN	syrup, oral	0121-1276OTC MONOGRAPH DRUG
Gabapentin	Gabapentin	solution, oral	0121-1067ANDA
Gabapentin	Gabapentin	solution, oral	0121-2134ANDA
Gabapentin	Gabapentin	solution, oral	0121-4067ANDA
Guaifenesin and Codeine Phosphate	Guaifenesin and Codeine Phosphate	solution, oral	0121-0775OTC MONOGRAPH DRUG
Guaifenesin and Codeine Phosphate	Guaifenesin and Codeine Phosphate	solution, oral	0121-1550OTC MONOGRAPH DRUG
Guaifenesin and Codeine Phosphate	Guaifenesin and Codeine Phosphate	solution, oral	0121-1775OTC MONOGRAPH DRUG
Haloperidol	Haloperidol	solution, oral	0121-0581ANDA
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE and ACETAMINOPHEN	solution, oral	0121-1544ANDA
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE and ACETAMINOPHEN	solution, oral	0121-2316ANDA
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE and ACETAMINOPHEN	solution, oral	0121-4772ANDA
Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide	solution, oral	0121-1036NDA AUTHORIZED GENERIC
Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	solution, oral	0121-1034ANDA
Infants Simethicone Drops	Infants Simethicone Drops	liquid, oral	0121-1094OTC MONOGRAPH DRUG
LACTULOSE	Lactulose	solution, oral	0121-0873ANDA
LACTULOSE	LACTULOSE	solution, oral	0121-1154ANDA
LACTULOSE	LACTULOSE	solution, oral	0121-1746ANDA
LACTULOSE	LACTULOSE	solution, oral	0121-4577ANDA
Lacosamide	Lacosamide	solution, oral	0121-1012ANDA
Lacosamide	Lacosamide	solution, oral	0121-2024ANDA
Lacosamide	Lacosamide	solution, oral	0121-3036ANDA
Lacosamide	Lacosamide	solution, oral	0121-4048ANDA
Lactulose	Lactulose	powder, for solution, oral	0121-0965ANDA
Lactulose	Lactulose	powder, for solution, oral	0121-1930ANDA
Levetiracetam	LEVETIRACETAM	solution, oral	0121-0799ANDA
Levetiracetam	LEVETIRACETAM	solution, oral	0121-1598ANDA
Levetiracetam	LEVETIRACETAM	solution, oral	0121-2397ANDA
Levetiracetam	LEVETIRACETAM	solution, oral	0121-4799ANDA
Lidocaine Hydrochloride	Lidocaine Hydrochloride	solution, oral	0121-0950ANDA
Lidocaine Hydrochloride	Lidocaine Hydrochloride	solution, topical	0121-0972ANDA
Lidocaine Hydrochloride	Lidocaine Hydrochloride	solution, oral	0121-4950ANDA
Lidocaine Pain Relief	Lidocaine Pain Relief	patch, topical	0121-0970OTC MONOGRAPH DRUG
Lincomycin	Lincomycin Hydrochloride	injection, intramuscular, intravenous	0121-1035ANDA
Lithium	Lithium	solution, oral	0121-1027ANDA
Lithium	Lithium	solution, oral	0121-4027ANDA
Mag-AL Liquid	Aluminum Hydroxide and Magnesium Hydroxide	suspension, oral	0121-1760OTC MONOGRAPH DRUG
Mag-AL Plus	Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone	suspension, oral	0121-1761OTC MONOGRAPH DRUG
Mag-AL Plus XS	Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone	suspension, oral	0121-1762OTC MONOGRAPH DRUG
Megestrol Acetate	Megestrol Acetate	suspension, oral	0121-0945ANDA
Megestrol Acetate	Megestrol Acetate	suspension, oral	0121-1038ANDA
Metoclopramide	metoclopramide hydrochloride	solution, oral	0121-0576ANDA
Metoclopramide	metoclopramide hydrochloride	solution, oral	0121-1576ANDA
Milk of Magnesia	Magnesium Hydroxide	suspension, oral	0121-0431OTC MONOGRAPH DRUG
Milk of Magnesia Concentrate	MAGNESIUM HYDROXIDE	suspension, oral	0121-0940OTC MONOGRAPH DRUG
Morphine Sulfate	Morphine Sulfate	solution, oral	0121-0904NDA
Morphine Sulfate	MORPHINE SULFATE	solution, oral	0121-4955ANDA
Mupirocin	Mupirocin	ointment, topical	0121-1076ANDA
Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	solution, oral	0121-0678ANDA
Nystatin	NYSTATIN	suspension, oral	0121-0868ANDA
Nystatin	NYSTATIN	suspension, oral	0121-1045ANDA
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	solution, oral	0121-0827ANDA
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	solution, oral	0121-4827ANDA
Olanzapine Intramuscular	Olanzapine	injection, powder, for solution, intramuscular	0121-1072ANDA
Ondansetron	Ondansetron	solution, oral	0121-0882ANDA
Ondansetron	Ondansetron	solution, oral	0121-4882ANDA
Pentamidine Isethionate	Pentamidine Isethionate	injection, powder, lyophilized, for solution, intramuscular, intravenous	0121-1101ANDA
Pentamidine Isethionate	Pentamidine Isethionate	inhalant, respiratory (inhalation)	0121-1102ANDA
Phenobarbital Oral Solution	Phenobarbital Oral	solution, oral	0121-0942UNAPPROVED DRUG OTHER
Phenobarbital Oral Solution	Phenobarbital Oral	solution, oral	0121-1884UNAPPROVED DRUG OTHER
Phenobarbital Oral Solution	Phenobarbital Oral	solution, oral	0121-2826UNAPPROVED DRUG OTHER
Phenytoin	Phenytoin	suspension, oral	0121-0892ANDA
Potassium Chloride	POTASSIUM CHLORIDE	solution, oral	0121-0948ANDA
Potassium Chloride	POTASSIUM CHLORIDE	solution, oral	0121-1896ANDA
Potassium Chloride	POTASSIUM CHLORIDE	solution, oral	0121-2847ANDA
Potassium Chloride	POTASSIUM CHLORIDE	solution, oral	0121-4948ANDA
Potassium Citrate and Citric Acid	Potassium Citrate and Citric Acid Monohydrate	solution, oral	0121-0676UNAPPROVED DRUG OTHER
PrednisoLONE Sodium Phosphate	PrednisoLONE Sodium Phosphate	solution, oral	0121-1100NDA
Prednisolone	Prednisolone	solution, oral	0121-0885ANDA
Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	solution, oral	0121-0759ANDA
Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	solution, oral	0121-0773ANDA
Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	solution, oral	0121-0777ANDA
Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	solution, oral	0121-4759ANDA
Promethazine DM	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	solution, oral	0121-1070ANDA
Promethazine Hydrochloride	Promethazine Hydrochloride	solution, oral	0121-1854ANDA
Propranolol Hydrochloride	Propranolol Hydrochloride	solution, oral	0121-0958ANDA
Propranolol Hydrochloride	Propranolol Hydrochloride	solution, oral	0121-4958ANDA
SULFATRIM	Sulfamethoxazole and Trimethoprim	suspension, oral	0121-0854NDA
Senna	sennosides	liquid, oral	0121-4967OTC MONOGRAPH DRUG
Sucralfate	Sucralfate	suspension, oral	0121-0974ANDA
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	suspension, oral	0121-0853NDA
THEOPHYLLINE	THEOPHYLLINE	solution, oral	0121-0820ANDA
THEOPHYLLINE	THEOPHYLLINE	solution, oral	0121-4820ANDA
TRICITRATES	POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE	solution, oral	0121-0677UNAPPROVED DRUG OTHER
Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	solution, oral	0121-0658ANDA
VALPROIC ACID	VALPROIC ACID	solution, oral	0121-0675ANDA
VALPROIC ACID	VALPROIC ACID	solution, oral	0121-1350ANDA
VALPROIC ACID	VALPROIC ACID	solution, oral	0121-4675ANDA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	capsule, oral	0121-1032ANDA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	capsule, oral	0121-1033ANDA
Voriconazole	Voriconazole Injection	injection, intravenous	0121-1091ANDA
buprenorphine hydrochloride	buprenorphine hydrochloride	tablet, sublingual	0121-1019ANDA
buprenorphine hydrochloride	buprenorphine hydrochloride	tablet, sublingual	0121-2038ANDA
calcium chloride	calcium chloride	injection, solution, intravenous	0121-1099ANDA
leuprolide acetate	leuprolide acetate	kit, subcutaneous	0121-2106ANDA

Neighbours

Registered in the same town

Bausch & Lomb Ireland LimitedGreenville, SC

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Enquiry

Common questions

Is PAI Holdings, LLC FDA approved?: PAI Holdings, LLC 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 PAI Holdings, LLC's drugs manufactured?: The FDA register lists Greenville, SC. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does PAI Holdings, LLC make?: 146 products are listed under PAI Holdings, LLC in the openFDA NDC Directory, most often as solution; suspension; liquid. 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.