hydrocodone bitartrate and ibuprofen (53746-116)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and ibuprofen

Generic Name hydrocodone bitartrate and ibuprofen

Labeler amneal pharmaceuticals of new york llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrocodone bitartrate 2.5 mg/1, ibuprofen 200 mg/1

Manufacturer

Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-116

Product ID 53746-116_e109d65b-643b-4c2e-80ad-30c7b3e9c160

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076642

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2010-02-18

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 53746116

Hyphenated Format 53746-116

Supplemental Identifiers

RxCUI

858770 858778 858798 859315

UPC

0353746117014 0353746145017 0353746116017 0353746146014

UNII

WK2XYI10QM NO70W886KK

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 ANDA076642 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2.5 mg/1
200 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (53746-116-01)

source: ndc

Packages (1)

53746-116-01 100 TABLET in 1 BOTTLE (53746-116-01)

Ingredients (2)

hydrocodone bitartrate (2.5 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": "e109d65b-643b-4c2e-80ad-30c7b3e9c160", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0353746117014", "0353746145017", "0353746116017", "0353746146014"], "unii": ["WK2XYI10QM", "NO70W886KK"], "rxcui": ["858770", "858778", "858798", "859315"], "spl_set_id": ["abc33718-4e88-43ea-9ffa-2b04ffc812ef"], "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": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-116-01)", "package_ndc": "53746-116-01", "marketing_start_date": "20100218"}], "brand_name": "Hydrocodone Bitartrate and Ibuprofen", "product_id": "53746-116_e109d65b-643b-4c2e-80ad-30c7b3e9c160", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "53746-116", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Ibuprofen", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Ibuprofen", "active_ingredients": [{"name": "HYDROCODONE BITARTRATE", "strength": "2.5 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA076642", "marketing_category": "ANDA", "marketing_start_date": "20100218", "listing_expiration_date": "20261231"}