hydrocodone bitartrate and acetaminophen (31722-997)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

Labeler camber pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, hydrocodone bitartrate 10 mg/1

Manufacturer

Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-997

Product ID 31722-997_d745e0ac-ee48-44c7-8430-8da0a69d2735

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211487

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2018-11-08

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722997

Hyphenated Format 31722-997

Supplemental Identifiers

RxCUI

856999 857002

UPC

0331722997010 0331722996013

UNII

NO70W886KK 362O9ITL9D

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 acetaminophen (source: ndc)

Generic Name hydrocodone bitartrate and acetaminophen (source: ndc)

Application Number ANDA211487 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (31722-997-01)
500 TABLET in 1 BOTTLE (31722-997-05)

source: ndc

Packages (2)

31722-997-01 100 TABLET in 1 BOTTLE (31722-997-01) 31722-997-05 500 TABLET in 1 BOTTLE (31722-997-05)

Ingredients (2)

acetaminophen (325 mg/1) hydrocodone bitartrate (10 mg/1)

Linked Drug Pages (1)

Hydrocodone Bitartrate and Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "d745e0ac-ee48-44c7-8430-8da0a69d2735", "openfda": {"upc": ["0331722997010", "0331722996013"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002"], "spl_set_id": ["ed6af366-753c-4f3b-a6a2-c9a183c50035"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (31722-997-01)", "package_ndc": "31722-997-01", "marketing_start_date": "20181108"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (31722-997-05)", "package_ndc": "31722-997-05", "marketing_start_date": "20181108"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "31722-997_d745e0ac-ee48-44c7-8430-8da0a69d2735", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "31722-997", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA211487", "marketing_category": "ANDA", "marketing_start_date": "20181108", "listing_expiration_date": "20261231"}