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 7.5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 87063-050
Product ID 87063-050_4ca4b03b-efbe-4d32-e063-6394a90af0f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210211
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2018-07-13

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 87063050
Hyphenated Format 87063-050

Supplemental Identifiers

UNII
NO70W886KK 362O9ITL9D

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 ANDA210211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 7.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (87063-050-01)
  • 5 TABLET in 1 BOTTLE (87063-050-05)
  • 7 TABLET in 1 BOTTLE (87063-050-07)
  • 10 TABLET in 1 BOTTLE (87063-050-10)
  • 14 TABLET in 1 BOTTLE (87063-050-14)
  • 20 TABLET in 1 BOTTLE (87063-050-20)
  • 30 TABLET in 1 BOTTLE (87063-050-30)
  • 60 TABLET in 1 BOTTLE (87063-050-60)
  • 90 TABLET in 1 BOTTLE (87063-050-90)
source: ndc

Packages (9)

87063-050-01 100 TABLET in 1 BOTTLE (87063-050-01) 87063-050-05 5 TABLET in 1 BOTTLE (87063-050-05) 87063-050-07 7 TABLET in 1 BOTTLE (87063-050-07) 87063-050-10 10 TABLET in 1 BOTTLE (87063-050-10) 87063-050-14 14 TABLET in 1 BOTTLE (87063-050-14) 87063-050-20 20 TABLET in 1 BOTTLE (87063-050-20) 87063-050-30 30 TABLET in 1 BOTTLE (87063-050-30) 87063-050-60 60 TABLET in 1 BOTTLE (87063-050-60) 87063-050-90 90 TABLET in 1 BOTTLE (87063-050-90)

Ingredients (2)

acetaminophen (325 mg/1) hydrocodone bitartrate (7.5 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": "4ca4b03b-efbe-4d32-e063-6394a90af0f3", "openfda": {"unii": ["NO70W886KK", "362O9ITL9D"], "spl_set_id": ["66e184cd-fa32-431f-b843-9c4bea12593b"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (87063-050-01)", "package_ndc": "87063-050-01", "marketing_start_date": "20251124"}, {"sample": false, "description": "5 TABLET in 1 BOTTLE (87063-050-05)", "package_ndc": "87063-050-05", "marketing_start_date": "20251124"}, {"sample": false, "description": "7 TABLET in 1 BOTTLE (87063-050-07)", "package_ndc": "87063-050-07", "marketing_start_date": "20251124"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (87063-050-10)", "package_ndc": "87063-050-10", "marketing_start_date": "20251124"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (87063-050-14)", "package_ndc": "87063-050-14", "marketing_start_date": "20251124"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (87063-050-20)", "package_ndc": "87063-050-20", "marketing_start_date": "20251124"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (87063-050-30)", "package_ndc": "87063-050-30", "marketing_start_date": "20251124"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (87063-050-60)", "package_ndc": "87063-050-60", "marketing_start_date": "20251124"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (87063-050-90)", "package_ndc": "87063-050-90", "marketing_start_date": "20251124"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "87063-050_4ca4b03b-efbe-4d32-e063-6394a90af0f3", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "87063-050", "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": "7.5 mg/1"}], "application_number": "ANDA210211", "marketing_category": "ANDA", "marketing_start_date": "20180713", "listing_expiration_date": "20271231"}