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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TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 76420-105-02 | Asclemed USA, Inc. | ANDA201952 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; CAFFEINE; ACETAMINOPHEN | 76420-802-12 | Asclemed USA, Inc. | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
CODEINE PHOSPHATE; ACETAMINOPHEN | 76420-103-03 | Asclemed USA, Inc. | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 76420-133-30 | Asclemed USA, Inc. | ANDA202991 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; CAFFEINE; ACETAMINOPHEN | 76420-802-05 | Asclemed USA, Inc. | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; CAFFEINE; ACETAMINOPHEN | 76420-802-60 | Asclemed USA, Inc. | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 76420-105-30 | Asclemed USA, Inc. | ANDA201952 | HUMAN PRESCRIPTION DRUG | ANDA |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 76420-983-01 | Asclemed USA, Inc. | ANDA090485 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 76420-215-30 | Asclemed USA, Inc. | ANDA202991 | HUMAN PRESCRIPTION DRUG | ANDA |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 76420-983-30 | Asclemed USA, Inc. | ANDA090485 | HUMAN PRESCRIPTION DRUG | ANDA |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 76420-105-01 | Asclemed USA, Inc. | ANDA201952 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 76420-215-60 | Asclemed USA, Inc. | ANDA202991 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 76420-372-15 | Asclemed USA, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 76420-983-03 | Asclemed USA, Inc. | ANDA090485 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; CAFFEINE; ACETAMINOPHEN | 76420-802-10 | Asclemed USA, Inc. | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; CAFFEINE; ACETAMINOPHEN | 76420-802-20 | Asclemed USA, Inc. | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 76420-209-60 | Asclemed USA, Inc. | ANDA201278 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; CAFFEINE; ACETAMINOPHEN | 76420-802-30 | Asclemed USA, Inc. | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 76420-209-90 | Asclemed USA, Inc. | ANDA201278 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 76420-257-30 | Asclemed USA, Inc. | ANDA202991 | HUMAN PRESCRIPTION DRUG | ANDA |
CODEINE PHOSPHATE; ACETAMINOPHEN | 76420-103-30 | Asclemed USA, Inc. | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 76420-215-01 | Asclemed USA, Inc. | ANDA202991 | HUMAN PRESCRIPTION DRUG | ANDA |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 76420-983-10 | Asclemed USA, Inc. | ANDA090485 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 76420-209-30 | Asclemed USA, Inc. | ANDA201278 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 76420-257-60 | Asclemed USA, Inc. | ANDA202991 | HUMAN PRESCRIPTION DRUG | ANDA |
CODEINE PHOSPHATE; ACETAMINOPHEN | 76420-103-10 | Asclemed USA, Inc. | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 76420-257-90 | Asclemed USA, Inc. | ANDA202991 | HUMAN PRESCRIPTION DRUG | ANDA |
WATER; ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; POLYMYXIN B SULFATE; ALCOHOL; BACITRACIN ZINC; NEOMYCIN SULFATE; HYDROCORTISONE; IBUPROFEN; ISOPROPYL ALCOHOL | 51142-002-01 | ASO LLC | 505G(a)(3) | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE | 81013-102-01 | Aspire Pharmaceuticals Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; GUAIFENESIN | 81013-105-01 | Aspire Pharmaceuticals Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
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