hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: bryant ranch prepack
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 bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, hydrocodone bitartrate 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-1177
Product ID 63629-1177_fc12f03d-145a-f3cf-e053-6294a90aa85b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207509
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-06-17

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636291177
Hyphenated Format 63629-1177

Supplemental Identifiers

RxCUI
856987
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 ANDA207509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (63629-1177-1)
source: ndc

Packages (1)

63629-1177-1 100 TABLET in 1 BOTTLE (63629-1177-1)

Ingredients (2)

acetaminophen (300 mg/1) hydrocodone bitartrate (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": "fc12f03d-145a-f3cf-e053-6294a90aa85b", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["856987"], "spl_set_id": ["2f6d0712-e756-49f2-a6b8-bbd160a454c4"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (63629-1177-1)", "package_ndc": "63629-1177-1", "marketing_start_date": "20190617"}], "brand_name": "hydrocodone bitartrate and acetaminophen", "product_id": "63629-1177_fc12f03d-145a-f3cf-e053-6294a90aa85b", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "63629-1177", "dea_schedule": "CII", "generic_name": "hydrocodone bitartrate and acetaminophen", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydrocodone bitartrate and acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA207509", "marketing_category": "ANDA", "marketing_start_date": "20190617", "listing_expiration_date": "20261231"}