NDC 57664-281

Hydrocodone bitartrate and ibuprofen

Hydrocodone Bitartrate And Ibuprofen

Hydrocodone bitartrate and ibuprofen is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Hydrocodone Bitartrate; Ibuprofen.

Product ID57664-281_5fc8dccb-c6eb-0b9a-e053-2a91aa0a7bad
NDC57664-281
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone bitartrate and ibuprofen
Generic NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA091633
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Active Ingredient Strength3 mg/1; mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57664-281-08

100 TABLET, FILM COATED in 1 BOTTLE (57664-281-08)
Marketing Start Date2013-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57664-281-83 [57664028183]

Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-28
Marketing End Date2015-05-31

NDC 57664-281-08 [57664028108]

Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-28
Marketing End Date2015-05-31

NDC 57664-281-88 [57664028188]

Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-28
Marketing End Date2015-05-31

NDC 57664-281-18 [57664028118]

Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-28
Marketing End Date2015-05-31

NDC 57664-281-13 [57664028113]

Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-28
Marketing End Date2015-05-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE2.5 mg/1

OpenFDA Data

SPL SET ID:7f9cfcc4-e4c1-4ece-a901-abc7cb89e2be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859315
  • 858798
  • 858770
  • 858778
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0357664281888
  • 0357664203880
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Opioid Agonist [EPC]
    • Opioid Agonists [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

    NDC Crossover Matching brand name "Hydrocodone bitartrate and ibuprofen" or generic name "Hydrocodone Bitartrate And Ibuprofen"

    NDCBrand NameGeneric Name
    0603-3584Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofen
    0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofen
    0603-3897Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofen
    13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    33261-378HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
    49999-588Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    68084-841Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    71335-0094HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
    71335-0104Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    55700-639Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    57664-203Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
    57664-280Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
    57664-281Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
    57664-102Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
    62037-524HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
    63629-5437Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    63739-557Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    67296-1282HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
    67296-1655Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    50991-579IBUDONEhydrocodone bitartrate and ibuprofen
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