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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PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68210-5001-1 | SPIRIT PHARMACEUTICALS LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68210-5002-1 | SPIRIT PHARMACEUTICALS LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68210-5003-4 | SPIRIT PHARMACEUTICALS LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68210-5005-1 | SPIRIT PHARMACEUTICALS LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68210-5005-2 | SPIRIT PHARMACEUTICALS LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68210-5005-4 | SPIRIT PHARMACEUTICALS LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 68210-5008-4 | Spirit Pharmaceuticals LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE | 68210-5012-1 | SPIRIT PHARMACEUTICALS LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 68210-5015-2 | Spirit Pharmaceuticals LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 68210-5016-1 | Spirit Pharmaceuticals LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 68210-5019-6 | Spirit Pharmaceuticals LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68210-5030-7 | Spirit Pharmaceuticals LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 68210-6111-2 | SPIRIT PHARMACEUTICALS LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 68210-6113-1 | Spirit Pharmaceutical LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
CODEINE PHOSPHATE; ACETAMINOPHEN; CAFFEINE; BUTALBITAL | 68258-2012-9 | Dispensing Solutions, Inc. | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; BUTALBITAL; ACETAMINOPHEN | 68308-219-01 | Mayne Pharma Inc. | ANDA089007 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; CAFFEINE; BUTALBITAL | 68308-220-01 | Mayne Pharma Inc. | ANDA089175 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 68308-475-47 | Mayne Pharma Inc. | ANDA090177 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 68308-480-47 | Mayne Pharma Inc. | ANDA090177 | HUMAN PRESCRIPTION DRUG | ANDA |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 68382-334-01 | Zydus Pharmaceuticals USA Inc. | ANDA090460 | HUMAN PRESCRIPTION DRUG | ANDA |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 68382-334-05 | Zydus Pharmaceuticals USA Inc. | ANDA090460 | HUMAN PRESCRIPTION DRUG | ANDA |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 68382-334-10 | Zydus Pharmaceuticals USA Inc. | ANDA090460 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 68387-214-30 | Keltman Pharmaceuticals, Inc. | part343 | HUMAN OTC DRUG | OTC monograph final |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 68387-230-01 | Keltman Pharmaceuticals, Inc. | ANDA089699 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 68387-230-10 | Keltman Pharmaceuticals, Inc. | ANDA089699 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 68387-230-12 | Keltman Pharmaceuticals, Inc. | ANDA089699 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 68387-230-15 | Keltman Pharmaceuticals, Inc. | ANDA089699 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 68387-230-30 | Keltman Pharmaceuticals, Inc. | ANDA089699 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 68387-230-40 | Keltman Pharmaceuticals, Inc. | ANDA089699 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 68387-230-50 | Keltman Pharmaceuticals, Inc. | ANDA089699 | HUMAN PRESCRIPTION DRUG | ANDA |
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