Register entry
- Registered sites
- 2
- Active NDC listings
- 106
- Labeller names
- 6
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing2Labelling1Finished drug manufacture2Packaging1sterilize1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Nivagen Pharmaceuticals LLC | 580 Garcia Ave, Pittsburg, California (CA) 94565, United States (USA) | Analytical testing, Finished drug manufacture | 3026171274118903906 |
| Nivagen Pharmaceuticals LLC | 3900 Duckhorn Drive, Sacramento, California (CA) 95834, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3032951869119378301 |
Catalogue
Drug listings by form and route
106106 active NDC listings: 100 human prescription drug, 4 drug for further processing, 2 human otc drug. By marketing category: ANDA 88, UNAPPROVED DRUG OTHER 12, DRUG FOR FURTHER PROCESSING 4, OTC MONOGRAPH DRUG 2.
| Dosage form | NDCs |
|---|---|
| tablet | 43 |
| capsule | 19 |
| tablet, film coated | 9 |
| tablet, coated | 8 |
| tablet, extended release | 7 |
| injection | 4 |
| cream | 3 |
| tablet, film coated, extended release | 3 |
| suspension | 2 |
| tablet, delayed release | 2 |
| injection, powder, lyophilized, for solution | 1 |
| kit | 1 |
| ointment | 1 |
| powder, for solution | 1 |
| solution | 1 |
| Route | NDCs |
|---|---|
| oral | 91 |
| intravenous | 5 |
| intramuscular | 4 |
| topical | 4 |
| rectal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| nivagen pharmaceuticals, inc. | 70 |
| nivagen pharmaceuticals, inc. | 19 |
| nivagen pharmaceuticals inc. | 9 |
| nivagen pharmaceuticals, inc | 4 |
| nivagen pharmaceuticals inc | 2 |
| nivagen pharmaceuticals, inc. | 2 |
Catalogue
Marketed products
106| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Acyclovir | Acyclovir | tablet, oral | 75834-122ANDA |
| Acyclovir | Acyclovir | tablet, oral | 75834-123ANDA |
| Acyclovir | Acyclovir | capsule, oral | 75834-124ANDA |
| Albuterol | albuterol sulfate | tablet, oral | 75834-273ANDA |
| Albuterol | albuterol sulfate | tablet, oral | 75834-274ANDA |
| Atorvastatin calcium | Atorvastatin calcium | tablet, oral | 75834-255ANDA |
| Atorvastatin calcium | Atorvastatin calcium | tablet, oral | 75834-256ANDA |
| Atorvastatin calcium | Atorvastatin calcium | tablet, oral | 75834-257ANDA |
| Atorvastatin calcium | Atorvastatin calcium | tablet, oral | 75834-258ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 75834-266ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 75834-267ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 75834-268ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 75834-269ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 75834-270ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 75834-236ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 75834-237ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 75834-238ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 75834-239ANDA |
| Calcium Acetate | Calcium Acetate | capsule, oral | 75834-323ANDA |
| Carbamazepine | Carbamazepine | tablet, oral | 75834-220ANDA |
| Carbamazepine | Carbamazepine | tablet, oral | 75834-221ANDA |
| Chlorthalidone | Chlorthalidone | tablet, oral | 75834-109ANDA |
| Chlorthalidone | Chlorthalidone | tablet, oral | 75834-110ANDA |
| DECITABINE | decitabine | injection, powder, lyophilized, for solution, intravenous | 75834-190ANDA |
| DICLOFENAC POTASSIUM | Diclofenac potassium | powder, for solution, oral | 75834-338ANDA |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | tablet, oral | 75834-327ANDA |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | tablet, oral | 75834-328ANDA |
| Diclofenac Potassium | Diclofenac Potassium Tablets | tablet, film coated, oral | 75834-337ANDA |
| Diclofenac Sodium Misoprostol | diclofenac sodium and misoprostol | tablet, delayed release, oral | 75834-264ANDA |
| Diclofenac Sodium Misoprostol | diclofenac sodium and misoprostol | tablet, delayed release, oral | 75834-265ANDA |
| ERYTHROMYCIN | ERYTHROMYCIN | tablet, film coated, oral | 75834-242ANDA |
| ERYTHROMYCIN | ERYTHROMYCIN | tablet, film coated, oral | 75834-243ANDA |
| Erythromycin Ethylsuccinate | Erythromycin Ethylsuccinate | suspension, oral | 75834-294ANDA |
| Erythromycin Ethylsuccinate | Erythromycin Ethylsuccinate | suspension, oral | 75834-295ANDA |
| GLYBURIDE | GLYBURIDE | tablet, oral | 75834-202ANDA |
| GLYBURIDE | GLYBURIDE | tablet, oral | 75834-203ANDA |
| GLYBURIDE | GLYBURIDE | tablet, oral | 75834-204ANDA |
| GLYCOPYRROLATE | glycopyrrolate | injection, intramuscular, intravenous | 75834-193ANDA |
| GLYCOPYRROLATE | glycopyrrolate | injection, intramuscular, intravenous | 75834-194ANDA |
| GLYCOPYRROLATE | glycopyrrolate | injection, intramuscular, intravenous | 75834-195ANDA |
| GLYCOPYRROLATE | glycopyrrolate | injection, intramuscular, intravenous | 75834-196ANDA |
| Gemfibrozil | Gemfibrozil | tablet, oral | 75834-131ANDA |
| HYDROCORTISONE ACETATE | HYDROCORTISONE ACETATE | suppository, rectal | 75834-147UNAPPROVED DRUG OTHER |
| HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE | PRAMOXINE HYDROCHLORIDE and HYDROCORTISONE ACETATE | cream, topical | 75834-197UNAPPROVED DRUG OTHER |
| Hydralazine | HYDRALAZINE HYDROCHLORIDE | tablet, oral | 75834-126ANDA |
| Hydralazine | HYDRALAZINE HYDROCHLORIDE | tablet, oral | 75834-127ANDA |
| Hydralazine | HYDRALAZINE HYDROCHLORIDE | tablet, oral | 75834-128ANDA |
| Hydroquinone 4% | Hydroquinone | cream, topical | 75834-137UNAPPROVED DRUG OTHER |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | tablet, oral | 75834-324ANDA |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | tablet, oral | 75834-325ANDA |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | tablet, oral | 75834-326ANDA |
| - | Metoprolol Succinate | tablet, extended release | 75834-290DRUG FOR FURTHER PROCESSING |
| - | Metoprolol Succinate | tablet, extended release | 75834-291DRUG FOR FURTHER PROCESSING |
| - | Metoprolol Succinate | tablet, extended release | 75834-292DRUG FOR FURTHER PROCESSING |
| - | Metoprolol Succinate | tablet, extended release | 75834-293DRUG FOR FURTHER PROCESSING |
| NATEGLINIDE | NATEGLINIDE | tablet, coated, oral | 75834-205ANDA |
| NATEGLINIDE | NATEGLINIDE | tablet, coated, oral | 75834-206ANDA |
| NIVAGEN ZINC OXIDE | zinc oxide | ointment, topical | 75834-170OTC MONOGRAPH DRUG |
| Niva Thyroid | thyroid, porcine | tablet, oral | 75834-310UNAPPROVED DRUG OTHER |
| Niva Thyroid | thyroid, porcine | tablet, oral | 75834-311UNAPPROVED DRUG OTHER |
| Niva Thyroid | thyroid, porcine | tablet, oral | 75834-312UNAPPROVED DRUG OTHER |
| Niva Thyroid | thyroid, porcine | tablet, oral | 75834-313UNAPPROVED DRUG OTHER |
| Niva Thyroid | thyroid, porcine | tablet, oral | 75834-314UNAPPROVED DRUG OTHER |
| Niva Thyroid | thyroid, porcine | tablet, oral | 75834-315UNAPPROVED DRUG OTHER |
| Niva Thyroid | thyroid, porcine | tablet, oral | 75834-316UNAPPROVED DRUG OTHER |
| Niva Thyroid | thyroid, porcine | tablet, oral | 75834-317UNAPPROVED DRUG OTHER |
| Norethindrone Acetate and Ethinyl Estradiol | Norethindrone Acetate and Ethinyl Estradiol | tablet, oral | 75834-129ANDA |
| Norethindrone Acetate and Ethinyl Estradiol | Norethindrone Acetate and Ethinyl Estradiol | tablet, oral | 75834-130ANDA |
| OFLOXACIN | OFLOXACIN | tablet, coated, oral | 75834-112ANDA |
| OFLOXACIN | OFLOXACIN | tablet, coated, oral | 75834-119ANDA |
| OFLOXACIN | OFLOXACIN | tablet, coated, oral | 75834-120ANDA |
| OFLOXACIN | OFLOXACIN | tablet, coated, oral | 75834-199ANDA |
| OFLOXACIN | OFLOXACIN | tablet, coated, oral | 75834-200ANDA |
| OFLOXACIN | OFLOXACIN | tablet, coated, oral | 75834-201ANDA |
| POTASSIUM IODIDE | POTASSIUM IODIDE | solution, oral | 75834-280UNAPPROVED DRUG OTHER |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | capsule, oral | 75834-133ANDA |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | capsule, oral | 75834-134ANDA |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | capsule, oral | 75834-135ANDA |
| RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE | capsule, oral | 75834-136ANDA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | tablet, oral | 75834-240ANDA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | tablet, oral | 75834-241ANDA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | tablet, oral | 75834-272ANDA |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | capsule, oral | 75834-207ANDA |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | capsule, oral | 75834-208ANDA |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | capsule, oral | 75834-209ANDA |
| Tadalafil | Tadalafil | tablet, film coated, oral | 75834-247ANDA |
| Tadalafil | Tadalafil | tablet, film coated, oral | 75834-248ANDA |
| Tadalafil | Tadalafil | tablet, film coated, oral | 75834-249ANDA |
| Tadalafil | Tadalafil | tablet, film coated, oral | 75834-250ANDA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | tablet, extended release, oral | 75834-217ANDA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | tablet, extended release, oral | 75834-218ANDA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | tablet, extended release, oral | 75834-219ANDA |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | tablet, film coated, extended release, oral | 75834-158ANDA |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | tablet, film coated, extended release, oral | 75834-159ANDA |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | tablet, film coated, extended release, oral | 75834-320ANDA |
| fluoxetine | fluoxetine hydrochloride | tablet, oral | 75834-148ANDA |
| lidocaine | lidocaine | cream, topical | 75834-333OTC MONOGRAPH DRUG |
| temozolomide | temozolomide | capsule, oral | 75834-132ANDA |
| temozolomide | temozolomide | capsule, oral | 75834-142ANDA |
| temozolomide | temozolomide | capsule, oral | 75834-143ANDA |
| temozolomide | temozolomide | capsule, oral | 75834-144ANDA |
| temozolomide | temozolomide | capsule, oral | 75834-145ANDA |
| temozolomide | temozolomide | capsule, oral | 75834-146ANDA |
| varenicline | varenicline | tablet, film coated, oral | 75834-334ANDA |
| varenicline | varenicline | tablet, film coated, oral | 75834-335ANDA |
| varenicline | varenicline | kit | 75834-336ANDA |
Neighbours
Registered in the same town
4- PETNET Solutions, Inc.SACRAMENTO, CA
- Cardinal Health 418, Inc.Sacramento, CA
- Analgesic Services IncSacramento, CA
- Orca Biosystems Inc.Sacramento, CA
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Enquiry
Common questions
- Is Nivagen Pharmaceuticals LLC FDA approved?
- Nivagen Pharmaceuticals LLC holds 2 FDA-registered establishments 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 Nivagen Pharmaceuticals LLC's drugs manufactured?
- The FDA register lists Pittsburg, CA; Sacramento, CA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does Nivagen Pharmaceuticals LLC make?
- 106 products are listed under Nivagen Pharmaceuticals LLC in the openFDA NDC Directory, most often as tablet; capsule; tablet, film coated. 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.