hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: asclemed 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 asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-215
Product ID 76420-215_dea38bcd-012c-0949-e053-2a95a90a8f7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202991
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-04-12

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420215
Hyphenated Format 76420-215

Supplemental Identifiers

RxCUI
856999
UNII
362O9ITL9D NO70W886KK

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 ANDA202991 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76420-215-01)
  • 30 TABLET in 1 BOTTLE (76420-215-30)
  • 60 TABLET in 1 BOTTLE (76420-215-60)
  • 90 TABLET in 1 BOTTLE (76420-215-90)
source: ndc

Packages (4)

76420-215-01 100 TABLET in 1 BOTTLE (76420-215-01) 76420-215-30 30 TABLET in 1 BOTTLE (76420-215-30) 76420-215-60 60 TABLET in 1 BOTTLE (76420-215-60) 76420-215-90 90 TABLET in 1 BOTTLE (76420-215-90)

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": "dea38bcd-012c-0949-e053-2a95a90a8f7b", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["856999"], "spl_set_id": ["5c00f98f-dcab-4bdb-901e-02eb873dea31"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-215-01)", "package_ndc": "76420-215-01", "marketing_start_date": "20220510"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-215-30)", "package_ndc": "76420-215-30", "marketing_start_date": "20220510"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-215-60)", "package_ndc": "76420-215-60", "marketing_start_date": "20220510"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-215-90)", "package_ndc": "76420-215-90", "marketing_start_date": "20220510"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "76420-215_dea38bcd-012c-0949-e053-2a95a90a8f7b", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "76420-215", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Asclemed USA, 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": "ANDA202991", "marketing_category": "ANDA", "marketing_start_date": "20160412", "listing_expiration_date": "20261231"}