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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IBUPROFEN; ACETAMINOPHEN | 0573-0145-72 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
IBUPROFEN; ACETAMINOPHEN | 0573-0145-89 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
IBUPROFEN; ACETAMINOPHEN | 0573-0145-99 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0147-09 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0147-18 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0147-36 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0147-72 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0147-86 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0147-90 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0147-91 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0147-93 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0147-94 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0147-95 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
CAFFEINE; ACETAMINOPHEN; BUTALBITAL | 0591-2640-01 | Actavis Pharma, Inc. | ANDA040885 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; ACETAMINOPHEN; BUTALBITAL | 0591-2640-05 | Actavis Pharma, Inc. | ANDA040885 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 0591-2641-01 | Actavis Pharma, Inc. | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE | 0591-3220-01 | Actavis Pharma, Inc. | NDA020232 | HUMAN PRESCRIPTION DRUG | NDA authorized generic |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 0591-3369-01 | Actavis Pharma, Inc. | ANDA088616 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 0591-3369-05 | Actavis Pharma, Inc. | ANDA088616 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; ACETAMINOPHEN | 0603-2540-21 | Par Pharmaceutical | ANDA089987 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 0615-8397-05 | NCS HealthCare of KY, LLC dba Vangard Labs | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 0615-8397-30 | NCS HealthCare of KY, LLC dba Vangard Labs | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 0615-8397-39 | NCS HealthCare of KY, LLC dba Vangard Labs | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 0615-8398-67 | NCS HealthCare of KY, LLC dba Vangard Labs | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 0615-8409-30 | NCS HealthCare of KY, LLC dba Vangard Labs | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 0615-8409-39 | NCS HealthCare of KY, LLC dba Vangard Labs | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 0615-8425-39 | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA215486 | HUMAN OTC DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 0713-0703-89 | G&W Laboratories, Inc. | ANDA040482 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0713-0704-89 | G&W Laboratories, Inc. | ANDA040482 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 0722-6670-01 | Nexgen Pharma, Inc. | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
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