NDC 13107-004

Hydrocodone Bitartrate and Ibuprofen

Hydrocodone Bitartrate And Ibuprofen

Hydrocodone Bitartrate and Ibuprofen is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurolife Pharma, Llc. The primary component is Hydrocodone Bitartrate; Ibuprofen.

Product ID13107-004_23c79ece-d199-4718-8893-a1864bec097e
NDC13107-004
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Bitartrate and Ibuprofen
Generic NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-06-02
Marketing CategoryANDA / ANDA
Application NumberANDA204575
Labeler NameAurolife Pharma, LLC
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 13107-004-01

100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01)
Marketing Start Date2016-06-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13107-004-05 [13107000405]

Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204575
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-02

NDC 13107-004-11 [13107000411]

Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204575
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-02

NDC 13107-004-99 [13107000499]

Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204575
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-02

NDC 13107-004-01 [13107000401]

Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204575
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-02

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE7.5 mg/1

Pharmacological Class

  • Opioid Agonist [EPC]
  • Opioid Agonists [MoA]
  • Cyclooxygenase Inhibitors [MoA]
  • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug [EPC]

Medicade Reported Pricing

13107004605 OXYCODONE-ACETAMINOPHEN 10-325 MG TAB

Pricing Unit: EA | Drug Type:

13107004601 OXYCODONE-ACETAMINOPHEN 10-325 MG TAB

Pricing Unit: EA | Drug Type:

13107004505 OXYCODONE-ACETAMINOPHEN 7.5-325 MG TABLET

Pricing Unit: EA | Drug Type:

13107004501 OXYCODONE-ACETAMINOPHEN 7.5-325 MG TABLET

Pricing Unit: EA | Drug Type:

13107004405 OXYCODONE-ACETAMINOPHEN 5-325 MG TABLET

Pricing Unit: EA | Drug Type:

13107004401 OXYCODONE-ACETAMINOPHEN 5-325 MG TABLET

Pricing Unit: EA | Drug Type:

13107000401 HYDROCODONE-IBUPROFEN 7.5-200

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Hydrocodone Bitartrate and Ibuprofen" or generic name "Hydrocodone Bitartrate And Ibuprofen"

NDCBrand NameGeneric Name
0603-3584Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofen
0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofen
0603-3897Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofen
13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
33261-378HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
49999-588Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
68084-841Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
71335-0094HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
71335-0104Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
55700-639Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
57664-203Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
57664-280Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
57664-281Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
57664-102Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
62037-524HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
63629-5437Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
63739-557Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
67296-1282HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
67296-1655Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
50991-579IBUDONEhydrocodone bitartrate and ibuprofen
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