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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HYDROCODONE BITARTRATE; ACETAMINOPHEN | 53217-265-90 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-266-12 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-266-15 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-266-20 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-266-24 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-266-30 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-266-60 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-266-90 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-267-12 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-267-15 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-267-20 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-267-24 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-267-30 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-267-60 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 53217-267-90 | Aidarex Pharmaceuticals LLC | ANDA201013 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE | 53217-370-20 | Aidarex Pharmaceuticals LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 53329-643-29 | Medline Industries, LP | ANDA076200 | HUMAN OTC DRUG | ANDA |
CAFFEINE; SALICYLIC ACID; ACETAMINOPHEN | 53329-988-30 | Medline Industries, LP | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 53345-004-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 53345-006-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 53345-010-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 53345-010-02 | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 53345-012-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE | 53345-013-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 53345-019-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 53345-019-02 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part343 | HUMAN OTC DRUG | OTC monograph not final |
DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 53345-020-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN | 53345-021-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 53345-025-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 53345-026-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part341 | HUMAN OTC DRUG | OTC monograph final |
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