NDC 12634-260

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 ID12634-260_34f02e3f-cc77-53e4-e054-00144ff88e88
NDC12634-260
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE BITARTRATE AND ACETAMINOPHEN
Generic NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-03-30
Marketing CategoryANDA / ANDA
Application NumberANDA090118
Labeler NameApotheca Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 12634-260-94

4 TABLET in 1 BOTTLE (12634-260-94)
Marketing Start Date2014-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-260-60 [12634026060]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-30
Marketing End Date2016-05-31

NDC 12634-260-79 [12634026079]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

NDC 12634-260-80 [12634026080]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-30

NDC 12634-260-91 [12634026091]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

NDC 12634-260-94 [12634026094]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

NDC 12634-260-57 [12634026057]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-30
Marketing End Date2016-05-31

NDC 12634-260-55 [12634026055]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

NDC 12634-260-40 [12634026040]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

NDC 12634-260-30 [12634026030]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01
Marketing End Date2016-06-10

NDC 12634-260-85 [12634026085]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

NDC 12634-260-50 [12634026050]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

NDC 12634-260-66 [12634026066]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

NDC 12634-260-00 [12634026000]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

NDC 12634-260-71 [12634026071]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA090118
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE7.5 mg/1

OpenFDA Data

SPL SET ID:fe743045-6501-4d99-ae8d-7b0f3e27c656
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857005

    • Pharmacological Class

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