FDA Application
-
NDC Search Results on Active Ingredient: ibuprofen
Click on Active Ingredient to view the label.
Ingredient Name | NDC | Company Name | Application Number or Regulatory Citation | Product Type | Marketing Category |
---|---|---|---|---|---|
IBUPROFEN | 0573-1769-89 | Haleon US Holdings LLC | NDA020402 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 24385-058-82 | Amerisource Bergen | ANDA077349 | HUMAN OTC DRUG | ANDA |
DIPHENHYDRAMINE CITRATE; IBUPROFEN | 0573-0164-44 | Haleon US Holdings LLC | NDA021394 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 51824-064-01 | New World Imports | ANDA079174 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 21130-585-90 | Safeway | ANDA072096 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 58602-803-08 | Aurohealth LLC | ANDA209235 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 53746-144-10 | Amneal Pharmaceuticals of New York LLC | ANDA072199 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 72476-358-05 | RETAIL BUSINESS SERVICES,LLC. | ANDA202312 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 71205-357-06 | Proficient Rx LP | ANDA072096 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 49483-133-37 | TIME CAP LABORATORIES, INC. | ANDA079205 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 58602-895-21 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 62936-0941-1 | INGLES MARKETS, INC. | ANDA075010 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 45865-639-30 | Medsource Pharmaceuticals | part343 | HUMAN OTC DRUG | OTC monograph not final |
IBUPROFEN; DIPHENHYDRAMINE CITRATE | 30142-050-60 | Kroger Company | ANDA079113 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 41163-185-02 | United Natural Foods, Inc. dba UNFI | ANDA079205 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 62207-320-89 | Granules India Limited | ANDA202312 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 41226-600-42 | Kroger Company | ANDA091239 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 61715-018-50 | Kinray | ANDA091355 | HUMAN OTC DRUG | ANDA |
IBUPROFEN; ACETAMINOPHEN | 0573-0147-72 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 0573-0184-32 | Haleon US Holdings LLC | NDA021374 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 58602-713-10 | Aurohealth LLC | ANDA208865 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 0363-0897-34 | Walgreen Company | ANDA074937 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 11822-6604-5 | Rite Aid Corporation | ANDA072096 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 62207-358-47 | Granules India Limited | ANDA202312 | HUMAN OTC DRUG | ANDA |
IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE | 58602-887-12 | Aurohealth LLC | ANDA210676 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 49348-927-09 | Strategic Sourcing Services LLC | ANDA077349 | HUMAN OTC DRUG | ANDA |
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 62011-0070-1 | Strategic Sourcing Services LLC | ANDA074567 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 58602-843-12 | Aurohealth LLC | ANDA207753 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 68210-4192-2 | Spirit Pharmaceuticals LLC | ANDA079174 | HUMAN OTC DRUG | ANDA |
IBUPROFEN | 62011-0015-1 | Strategic Sourcing Services LLC | ANDA072096 | HUMAN OTC DRUG | ANDA |
-