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 | 68998-104-06 | MARC GLASSMAN, INC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 68998-095-02 | Marc Glassman, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 68998-004-04 | Marc Glassman, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 68998-198-02 | MARC GLASSMAN, INC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN | 68998-219-05 | MARC GLASSMAN, INC. | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE | 68998-139-02 | Marc Glassman, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 68998-392-01 | MARC GLASSMAN, INC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE | 75940-141-02 | MarcasUSA LLC | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE | 75940-141-24 | MarcasUSA LLC | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
ACETAMINOPHEN; ASPIRIN; CAFFEINE | 78612-110-20 | Marga Labs, LLC | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 78612-100-20 | Marga Labs, LLC | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
ACETAMINOPHEN | 25000-108-08 | MARKSANS PHARMA LIMITED | ANDA215486 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 25000-080-07 | MARKSANS PHARMA LIMITED | ANDA216994 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 25000-108-02 | MARKSANS PHARMA LIMITED | ANDA215486 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 25000-080-74 | MARKSANS PHARMA LIMITED | ANDA216994 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 25000-080-72 | MARKSANS PHARMA LIMITED | ANDA216994 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 25000-071-02 | MARKSANS PHARMA LIMITED | ANDA215486 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 25000-071-10 | MARKSANS PHARMA LIMITED | ANDA215486 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 25000-071-11 | MARKSANS PHARMA LIMITED | ANDA215486 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 25000-071-45 | MARKSANS PHARMA LIMITED | ANDA215486 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 25000-071-08 | MARKSANS PHARMA LIMITED | ANDA215486 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 10135-152-01 | Marlex Pharmaceuticals Inc | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 10135-123-01 | Marlex Pharmaceuticals Inc | part343 | HUMAN OTC DRUG | OTC monograph not final |
CAFFEINE; BUTALBITAL; ACETAMINOPHEN | 10135-628-01 | Marlex Pharmaceuticals Inc | ANDA207118 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 58154-100-01 | MATERNAL SCIENCE, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 58154-104-01 | MATERNAL SCIENCE, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
BUTALBITAL; CAFFEINE; ACETAMINOPHEN | 51862-179-01 | Mayne Pharma | ANDA089007 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; BUTALBITAL; ACETAMINOPHEN | 51862-540-01 | Mayne Pharma | ANDA089175 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; BUTALBITAL | 51862-544-05 | Mayne Pharma | ANDA207313 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; BUTALBITAL; ACETAMINOPHEN | 51862-540-05 | Mayne Pharma | ANDA089175 | HUMAN PRESCRIPTION DRUG | ANDA |
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