NDC 68387-230

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 Keltman Pharmaceuticals Inc.. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID68387-230_5d819e04-2719-49b2-be5c-f7967563b3fa
NDC68387-230
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE BITARTRATE AND ACETAMINOPHEN
Generic NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA089699
Labeler NameKeltman Pharmaceuticals Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68387-230-10

10 TABLET in 1 BOTTLE, PLASTIC (68387-230-10)
Marketing Start Date2010-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68387-230-10 [68387023010]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA089699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-22
Inactivation Date2019-10-29

NDC 68387-230-51 [68387023051]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA089699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-22
Inactivation Date2019-10-29

NDC 68387-230-01 [68387023001]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA089699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-22
Inactivation Date2019-10-29

NDC 68387-230-15 [68387023015]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA089699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-22
Inactivation Date2019-10-29

NDC 68387-230-50 [68387023050]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA089699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-22
Inactivation Date2019-10-29

NDC 68387-230-30 [68387023030]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA089699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-22
Inactivation Date2019-10-29

NDC 68387-230-90 [68387023090]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA089699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-22
Inactivation Date2019-10-29

NDC 68387-230-12 [68387023012]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA089699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-22
Inactivation Date2019-10-29

NDC 68387-230-40 [68387023040]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA089699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-01
Inactivation Date2019-10-29

NDC 68387-230-60 [68387023060]

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Marketing CategoryANDA
Application NumberANDA089699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-22
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE7.5 mg/1

OpenFDA Data

SPL SET ID:0af451fc-67e6-454b-88e7-ab5746f6dbb5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857118

    • 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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