NDC 45865-411

HYDROCODONE BIT/APAP

Hydrocodone Bitartrate And Acetaminophen

HYDROCODONE BIT/APAP is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID45865-411_1e13cbb2-936a-4919-e054-00144ff8d46c
NDC45865-411
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE BIT/APAP
Generic NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA040400
Labeler NameMedsource Pharmaceuticals
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 45865-411-06

6 TABLET in 1 BOTTLE (45865-411-06)
Marketing Start Date2011-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-411-52 [45865041152]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-60 [45865041160]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-49 [45865041149]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-06 [45865041106]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-57 [45865041157]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-40 [45865041140]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-12 [45865041112]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-15 [45865041115]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-51 [45865041151]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-59 [45865041159]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-30 [45865041130]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

NDC 45865-411-20 [45865041120]

HYDROCODONE BIT/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040400
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE10 mg/1

OpenFDA Data

SPL SET ID:53b3ed76-db40-4aa8-8c55-21991d557b42
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856999

    • Pharmacological Class

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

    NDC Crossover Matching brand name "HYDROCODONE BIT/APAP" or generic name "Hydrocodone Bitartrate And Acetaminophen"

    NDCBrand NameGeneric Name
    45865-411HYDROCODONE BIT/APAPHYDROCODONE BIT/APAP
    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
    0023-6002NorcoHydrocodone Bitartrate and Acetaminophen
    0023-6021NorcoHydrocodone Bitartrate and Acetaminophen
    0023-6022NorcoHydrocodone Bitartrate and Acetaminophen
    0074-3041VicodinHydrocodone Bitartrate and Acetaminophen
    0074-3043VicodinHydrocodone Bitartrate and Acetaminophen
    0074-3054VicodinHydrocodone Bitartrate and Acetaminophen
    0121-1542ZamicetHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0121-2313ZamicetHYDROCODONE BITARTRATE and ACETAMINOPHEN
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