NDC 12634-616

Hydrocodone Bitartrate and Acetaminophen

Hydrocodone Bitartrate And Acetaminophen

Hydrocodone Bitartrate and Acetaminophen is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Apotheca, Inc. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID12634-616_91924151-259e-4f6b-869c-01ba4a4729ae
NDC12634-616
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Bitartrate and Acetaminophen
Generic NameHydrocodone Bitartrate And Acetaminophen
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2014-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA040838
Labeler NameApotheca, Inc
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength8 mg/120mL; mg/120mL
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 12634-616-04

120 mL in 1 BOTTLE (12634-616-04)
Marketing Start Date2014-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-616-04 [12634061604]

Hydrocodone Bitartrate and Acetaminophen SOLUTION
Marketing CategoryANDA
Application NumberANDA040838
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE7.5 mg/120mL

OpenFDA Data

SPL SET ID:fe6e60c8-53de-4b77-825d-b7427a63f54c
Manufacturer
UNII

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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