NDC 12634-144

Hydrocodone Bitartrate and Acetaminophen

Hydrocodone Bitartrate And Acetaminophen

Hydrocodone Bitartrate and Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Apotheca, Inc.. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID12634-144_68fe60f5-37c3-4256-9c9d-33d3e3580a90
NDC12634-144
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Bitartrate and Acetaminophen
Generic NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-03-20
Marketing CategoryANDA / ANDA
Application NumberANDA040746
Labeler NameApotheca, Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength10 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 12634-144-79

25 TABLET in 1 BOTTLE (12634-144-79)
Marketing Start Date2009-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-144-52 [12634014452]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-04-13
Inactivation Date2020-01-31

NDC 12634-144-71 [12634014471]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-23
Inactivation Date2020-01-31

NDC 12634-144-61 [12634014461]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-04-13
Inactivation Date2020-01-31

NDC 12634-144-78 [12634014478]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-04-13
Inactivation Date2020-01-31

NDC 12634-144-55 [12634014455]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-04-13
Inactivation Date2020-01-31

NDC 12634-144-91 [12634014491]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-20
Inactivation Date2020-01-31

NDC 12634-144-85 [12634014485]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-04-13
Inactivation Date2020-01-31

NDC 12634-144-79 [12634014479]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE10 mg/1

OpenFDA Data

SPL SET ID:fcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857107
  • 856999
  • 857383

    • Pharmacological Class

    • Opioid Agonist [EPC]
    • Opioid Agonists [MoA]

    NDC Crossover Matching brand name "Hydrocodone Bitartrate and Acetaminophen" or generic name "Hydrocodone Bitartrate And Acetaminophen"

    NDCBrand NameGeneric Name
    0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0245-0410Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    68071-4801Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    68084-895Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    68084-884Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    68084-863Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And Acetaminophen
    68094-714Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    68387-230HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN
    68387-235Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    68788-6352Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    68788-9137Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And Acetaminophen
    68788-9141Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And Acetaminophen
    68788-9125Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And Acetaminophen
    68788-9297Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    68788-9250Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0527-1647Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0527-1649Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0527-1648Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0527-1651Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0527-1646Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0527-1650Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    69101-600HYDROCODONE BITARTRATE and ACETAMINOPHENHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0591-2174Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0591-2175Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0591-2171Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0591-2605Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0591-2612Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0591-2172Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0591-2176Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0603-3887Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And Acetaminophen
    0603-3890Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And Acetaminophen
    0603-3891Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And Acetaminophen
    71335-0063HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN
    71335-0108Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    71335-0385HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN
    71335-0466Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    71335-0960Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    71930-020Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    71930-019Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    71930-021Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    76519-1079HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN
    75921-881Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And Acetaminophen
    76519-1081HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN
    0713-0704Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0904-6421Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0904-6420Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0904-6567Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.