hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen
Generic Name hydrocodone bitartrate and acetaminophen
Labeler hikma pharmaceuticals usa inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/15mL, hydrocodone bitartrate 10 mg/15mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0843
Product ID 0054-0843_250056d2-c06c-76f1-e063-6394a90aec19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040881
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2025-06-02

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540843
Hyphenated Format 0054-0843

Supplemental Identifiers

RxCUI
1044427
UNII
362O9ITL9D NO70W886KK

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 ANDA040881 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/15mL
  • 10 mg/15mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0054-0843-63)
source: ndc

Packages (1)

0054-0843-63 473 mL in 1 BOTTLE (0054-0843-63)

Ingredients (2)

acetaminophen (300 mg/15mL) hydrocodone bitartrate (10 mg/15mL)

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": "250056d2-c06c-76f1-e063-6394a90aec19", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["1044427"], "spl_set_id": ["995a6cc7-8b72-4d35-b3b4-8c5752438fb7"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0054-0843-63)", "package_ndc": "0054-0843-63", "marketing_start_date": "20250616"}], "brand_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "product_id": "0054-0843_250056d2-c06c-76f1-e063-6394a90aec19", "dosage_form": "LIQUID", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0054-0843", "dea_schedule": "CII", "generic_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/15mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/15mL"}], "application_number": "ANDA040881", "marketing_category": "ANDA", "marketing_start_date": "20250602", "listing_expiration_date": "20261231"}