Hydrocodone Bitartrate and Acetaminophen

Generic: Hydrocodone Bitartrate and Acetaminophen

Labeler: Genus Lifesciences Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Hydrocodone Bitartrate and Acetaminophen
Generic Name Hydrocodone Bitartrate and Acetaminophen
Labeler Genus Lifesciences Inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ACETAMINOPHEN 325 mg/15mL, HYDROCODONE BITARTRATE 10 mg/15mL

Identifiers & Regulatory

Product NDC 64950-375
Product ID 64950-375_fa050a02-91ac-48c9-9cc4-6336739a3e26
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040834
DEA Schedule CII
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64950375
Hyphenated Format 64950-375

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 ANDA040834 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 10 mg/15mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (64950-375-16)
source: ndc

Packages (1)

64950-375-16 473 mL in 1 BOTTLE (64950-375-16)

Ingredients (2)

ACETAMINOPHEN (325 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": "fa050a02-91ac-48c9-9cc4-6336739a3e26", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["856944"], "spl_set_id": ["21632169-6b72-4252-9f76-50e2f6739541"], "manufacturer_name": ["Genus Lifesciences Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (64950-375-16)", "package_ndc": "64950-375-16", "marketing_start_date": "20240501"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "64950-375_fa050a02-91ac-48c9-9cc4-6336739a3e26", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "64950-375", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Genus Lifesciences Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/15mL"}], "application_number": "ANDA040834", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}