NDC 52959-324

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 H.j. Harkins Company, Inc.. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID52959-324_76b7cd4b-14ea-7025-e053-2991aa0a16fd
NDC52959-324
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE BITARTRATE AND ACETAMINOPHEN
Generic NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-12-29
Marketing CategoryANDA / ANDA
Application NumberANDA201013
Labeler NameH.J. Harkins Company, Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength10 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52959-324-24

24 TABLET in 1 BOTTLE (52959-324-24)
Marketing Start Date2015-12-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-324-12 [52959032412]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-02 [52959032402]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-10 [52959032410]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-24 [52959032424]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-04 [52959032404]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-90 [52959032490]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-60 [52959032460]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-40 [52959032440]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-15 [52959032415]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-28 [52959032428]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-00 [52959032400]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-20 [52959032420]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-75 [52959032475]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

NDC 52959-324-30 [52959032430]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA201013
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE10 mg/1

OpenFDA Data

SPL SET ID:76b7cd4b-14e9-7025-e053-2991aa0a16fd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856999

    • 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
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