hydrocodone bitartrate and ibuprofen (13107-004)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and ibuprofen

Generic Name hydrocodone bitartrate and ibuprofen

Labeler aurolife pharma, llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrocodone bitartrate 7.5 mg/1, ibuprofen 200 mg/1

Manufacturer

Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-004

Product ID 13107-004_ef408ee9-6806-423f-9998-53d81cc71b94

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204575

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2016-06-02

Pharmacologic Class

Established (EPC)

nonsteroidal anti-inflammatory drug [epc]

Mechanism of Action

cyclooxygenase inhibitors [moa]

Chemical Structure

anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107004

Hyphenated Format 13107-004

Supplemental Identifiers

RxCUI

858798

UPC

0313107004018

UNII

NO70W886KK WK2XYI10QM

NUI

N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydrocodone bitartrate and ibuprofen (source: ndc)

Generic Name hydrocodone bitartrate and ibuprofen (source: ndc)

Application Number ANDA204575 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

7.5 mg/1
200 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01)
500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05)
10 TABLET, FILM COATED in 1 BOTTLE (13107-004-11)
1000 TABLET, FILM COATED in 1 BOTTLE (13107-004-99)

source: ndc

Packages (4)

13107-004-01 100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01) 13107-004-05 500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05) 13107-004-11 10 TABLET, FILM COATED in 1 BOTTLE (13107-004-11) 13107-004-99 1000 TABLET, FILM COATED in 1 BOTTLE (13107-004-99)

Ingredients (2)

hydrocodone bitartrate (7.5 mg/1) ibuprofen (200 mg/1)

Linked Drug Pages (1)

Hydrocodone Bitartrate and Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "ef408ee9-6806-423f-9998-53d81cc71b94", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0313107004018"], "unii": ["NO70W886KK", "WK2XYI10QM"], "rxcui": ["858798"], "spl_set_id": ["470df63a-5c0f-42df-9023-a330a901153e"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01)", "package_ndc": "13107-004-01", "marketing_start_date": "20160602"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05)", "package_ndc": "13107-004-05", "marketing_start_date": "20160602"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (13107-004-11)", "package_ndc": "13107-004-11", "marketing_start_date": "20160602"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (13107-004-99)", "package_ndc": "13107-004-99", "marketing_start_date": "20160602"}], "brand_name": "Hydrocodone Bitartrate and Ibuprofen", "product_id": "13107-004_ef408ee9-6806-423f-9998-53d81cc71b94", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "13107-004", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Ibuprofen", "labeler_name": "Aurolife Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Ibuprofen", "active_ingredients": [{"name": "HYDROCODONE BITARTRATE", "strength": "7.5 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA204575", "marketing_category": "ANDA", "marketing_start_date": "20160602", "listing_expiration_date": "20261231"}