NDC 63629-5428

Hydrocodone Bitartate and Acetaminophen

Hydrocodone Bitartrate, Acetaminophen

Hydrocodone Bitartate and Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID63629-5428_c25d8e7a-71f2-4238-a281-501fe2878be4
NDC63629-5428
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Bitartate and Acetaminophen
Generic NameHydrocodone Bitartrate, Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-05-17
Marketing CategoryANDA / ANDA
Application NumberANDA040846
Labeler NameBryant Ranch Prepack
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength3 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63629-5428-2

30 TABLET in 1 BOTTLE (63629-5428-2)
Marketing Start Date2012-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5428-6 [63629542806]

Hydrocodone Bitartate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040846
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17
Inactivation Date2020-01-31

NDC 63629-5428-7 [63629542807]

Hydrocodone Bitartate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040846
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17
Inactivation Date2020-01-31

NDC 63629-5428-5 [63629542805]

Hydrocodone Bitartate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040846
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17
Inactivation Date2020-01-31

NDC 63629-5428-2 [63629542802]

Hydrocodone Bitartate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040846
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17
Inactivation Date2020-01-31

NDC 63629-5428-1 [63629542801]

Hydrocodone Bitartate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040846
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17
Inactivation Date2020-01-31

NDC 63629-5428-4 [63629542804]

Hydrocodone Bitartate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040846
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17
Inactivation Date2020-01-31

NDC 63629-5428-3 [63629542803]

Hydrocodone Bitartate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040846
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE2.5 mg/1

OpenFDA Data

SPL SET ID:06cd8ce6-8416-4747-b563-d88814539e12
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857391
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0904-6419Hydrocodone Bitartate and AcetaminophenHydrocodone Bitartate and Acetaminophen
    33261-881Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHEN
    42254-300Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHEN
    51655-900HYDROCODONE BITARTATE AND ACETAMINOPHENHYDROCODONE BITARTATE AND ACETAMINOPHEN
    63629-5428Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHEN
    76519-1011Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHEN
    17856-0640Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate, Acetaminophen
    64376-640Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate, Acetaminophen
    54348-066HYDROCODONE/APAPHYDROCODONE BITARTRATE, ACETAMINOPHEN

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