FDA Application
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NDC Search Results on Active Ingredient: ibuprofen
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; IBUPROFEN | 0573-0145-89 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 58602-893-29 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 58602-895-79 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 58602-895-78 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 79481-0503-2 | Meijer, Inc. | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 72657-157-72 | GLENMARK THERAPEUTICS INC., USA | ANDA218311 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 0363-5220-68 | Walgreen Company | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 0363-5220-16 | Walgreen Company | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 0113-5300-16 | L Perrigo Company | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 76162-501-23 | Topco Associates LLC | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 11822-5777-2 | Rite Aid Corporation | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 72657-157-74 | GLENMARK THERAPEUTICS INC., USA | ANDA218311 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 58602-893-62 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 62207-588-32 | Granules India Limited | BULK INGREDIENT | Export only | |
ACETAMINOPHEN; IBUPROFEN | 79903-148-72 | WALMART INC. | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 55910-441-68 | Dolgencorp Inc | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 58602-893-78 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 46122-742-68 | AMERISOURCE BERGEN | ANDA216999 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0145-99 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 58602-895-96 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 58602-895-51 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 72657-157-05 | GLENMARK THERAPEUTICS INC., USA | ANDA218311 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0145-18 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 58602-895-49 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 79481-0503-0 | Meijer, Inc. | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 58602-893-85 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 58602-895-11 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; LIDOCAINE; ALCOHOL; ASPIRIN; POLYMYXIN B SULFATE; BENZALKONIUM CHLORIDE; NEOMYCIN SULFATE; BACITRACIN ZINC; BENZOCAINE; IBUPROFEN; WATER | 52124-0111-1 | Genuine First Aid LLC | part333 | HUMAN OTC DRUG | OTC monograph final |
ALCOHOL; ASPIRIN; IBUPROFEN; POLYMYXIN B SULFATE; BACITRACIN ZINC; ACETAMINOPHEN; NEOMYCIN SULFATE; BENZALKONIUM CHLORIDE; BENZOCAINE | 44224-2500-1 | Tender Corporation DBA Adventure Ready Brands | part333B | HUMAN OTC DRUG | OTC monograph not final |
ASCORBIC ACID; HYPERICUM PERFORATUM; CINCHONA OFFICINALIS BARK; SALIX ALBA BARK; ALPHA-TOCOPHEROL; ASPIRIN; ARSENIC TRIOXIDE; TOXICODENDRON PUBESCENS LEAF; AMARYLLIS BELLADONNA WHOLE; CAPSICUM; IBUPROFEN; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; VITAMIN A; CAUSTICUM; ACETAMINOPHEN; GINGER | 63083-2046-2 | Professional Complementary Health Formulas | HUMAN OTC DRUG | unapproved homeopathic |
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