FDA Application
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NDC Search Results on Active Ingredient: acetaminophen
Click on Active Ingredient to view the label.
Ingredient Name | NDC | Company Name | Application Number or Regulatory Citation | Product Type | Marketing Category |
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ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 0135-7021-01 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 0135-7021-02 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 0135-7021-03 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 0135-7031-01 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
CAFFEINE; BUTALBITAL; ACETAMINOPHEN | 0143-0170-01 | West-Ward Pharmaceutical Corp | ANDA040261 | HUMAN PRESCRIPTION DRUG | ANDA |
IBUPROFEN; ACETAMINOPHEN | 0143-9150-01 | Hikma Pharmaceuticals USA Inc. | NDA215320 | HUMAN PRESCRIPTION DRUG | NDA |
IBUPROFEN; ACETAMINOPHEN | 0143-9150-10 | Hikma Pharmaceuticals USA Inc. | NDA215320 | HUMAN PRESCRIPTION DRUG | NDA |
ACETAMINOPHEN | 0143-9386-01 | Hikma Pharmaceuticals USA Inc. | NDA206968 | HUMAN PRESCRIPTION DRUG | NDA |
ACETAMINOPHEN | 0143-9386-10 | Hikma Pharmaceuticals USA Inc. | NDA206968 | HUMAN PRESCRIPTION DRUG | NDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0245-0410-01 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0245-0410-11 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0245-0410-50 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0245-0410-89 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 0245-0411-01 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 0245-0411-11 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 0245-0411-50 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 0245-0411-89 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0245-0412-01 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0245-0412-11 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0245-0412-50 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0245-0412-89 | Upsher-Smith Laboratories, LLC | ANDA206484 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 0254-2034-01 | Par Pharmaceutical, Inc. | ANDA202935 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 0254-2035-01 | Par Pharmaceutical, Inc. | ANDA202935 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0254-2036-01 | Par Pharmaceutical, Inc. | ANDA202935 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 0264-4050-80 | B. Braun Medical Inc. | NDA204957 | HUMAN PRESCRIPTION DRUG | NDA |
ACETAMINOPHEN | 0264-4050-90 | B. Braun Medical Inc. | NDA204957 | HUMAN PRESCRIPTION DRUG | NDA |
ACETAMINOPHEN | 0264-4100-90 | B. Braun Medical Inc. | NDA204957 | HUMAN PRESCRIPTION DRUG | NDA |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 0280-0022-01 | Bayer HealthCare LLC. | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 0280-0022-02 | Bayer HealthCare LLC. | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 0280-0022-03 | Bayer HealthCare LLC. | part341 | HUMAN OTC DRUG | OTC monograph final |
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