NDC 0406-0378

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 Specgx Llc. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID0406-0378_6a499c52-0786-477e-aef2-e1024759440a
NDC0406-0378
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Bitartrate and Acetaminophen
Generic NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA206718
Labeler NameSpecGx LLC
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 Through2022-12-31

Packaging

NDC 0406-0378-01

100 TABLET in 1 BOTTLE (0406-0378-01)
Marketing Start Date2017-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-0378-05 [00406037805]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA206718
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-31

NDC 0406-0378-01 [00406037801]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA206718
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-31

NDC 0406-0378-62 [00406037862]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA206718
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-31

NDC 0406-0378-23 [00406037823]

Hydrocodone Bitartrate and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA206718
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE10 mg/1

OpenFDA Data

SPL SET ID:d621b526-4d9a-48a9-9a3e-d29d6aea2f31
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856992
  • 856987
  • 856980
    • UPC Code
  • 0304060378056
  • 0304060377059
  • 0304060376052

    • 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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