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; CAFFEINE; PYRILAMINE MALEATE | 68016-736-24 | Chain Drug Consortium | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68016-754-06 | Premier Value | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 68016-755-06 | Premier Value | part341 | HUMAN OTC DRUG | OTC monograph final |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 68016-761-00 | PHARMACY VALUE ALLIANCE, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 68016-762-00 | PHARMACY VALUE ALLIANCE, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 68016-797-16 | Chain Drug Consortium, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE | 68016-798-16 | Chain Drug Consortium, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 68016-799-48 | Chain Drug Consortium, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 68016-877-16 | Chain Drug Consortium, LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 68016-877-24 | Chain Drug Consortium, LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 68016-878-16 | Chain Drug Consortium, LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 68016-878-24 | Chain Drug Consortium, LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 68016-879-48 | Chain Drug Consortium, LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
BUTALBITAL; ACETAMINOPHEN | 68047-721-01 | Larken Laboratories, Inc. | ANDA203484 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; ACETAMINOPHEN | 68047-721-30 | Larken Laboratories, Inc. | ANDA203484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; BUTALBITAL | 68047-752-01 | Larken Laboratories, Inc. | ANDA203484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; BUTALBITAL | 68047-752-30 | Larken Laboratories, Inc. | ANDA203484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; BUTALBITAL | 68047-753-01 | Larken Laboratories, Inc. | ANDA203484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; BUTALBITAL | 68047-753-30 | Larken Laboratories, Inc. | ANDA203484 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 68071-1552-5 | NuCare Pharmaceuticals,Inc. | ANDA076200 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 68071-2201-3 | NuCare Pharmaceuticals,Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 68071-2351-1 | NuCare Pharmaceuticals,Inc. | ANDA207152 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; ACETAMINOPHEN; BUTALBITAL | 68071-2365-3 | NuCare Pharmaceuticals,Inc. | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; ACETAMINOPHEN; BUTALBITAL | 68071-2365-6 | NuCare Pharmaceuticals,Inc. | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; ACETAMINOPHEN; BUTALBITAL | 68071-2365-8 | NuCare Pharmaceuticals,Inc. | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; ACETAMINOPHEN; BUTALBITAL | 68071-2365-9 | NuCare Pharmaceuticals,Inc. | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 68071-2470-1 | NuCare Pharmaceuticals,Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 68071-2481-2 | NuCare Pharmaceuticals,Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 68071-2481-3 | NuCare Pharmaceuticals,Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 68071-2481-4 | NuCare Pharmaceuticals,Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
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