hydrocodone/apap

Generic: hydrocodone/apap

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocodone/apap
Generic Name hydrocodone/apap
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, hydrocodone bitartrate 5 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-649
Product ID 72189-649_4a188f02-629f-25cf-e063-6394a90a5766
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210211
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2025-11-25

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189649
Hyphenated Format 72189-649

Supplemental Identifiers

RxCUI
857002
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/apap (source: ndc)
Generic Name hydrocodone/apap (source: ndc)
Application Number ANDA210211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (72189-649-20)
  • 30 TABLET in 1 BOTTLE (72189-649-30)
  • 60 TABLET in 1 BOTTLE (72189-649-60)
source: ndc

Packages (3)

72189-649-20 20 TABLET in 1 BOTTLE (72189-649-20) 72189-649-30 30 TABLET in 1 BOTTLE (72189-649-30) 72189-649-60 60 TABLET in 1 BOTTLE (72189-649-60)

Ingredients (2)

acetaminophen (325 mg/1) hydrocodone bitartrate (5 mg/1)

Linked Drug Pages (1)

Hydrocodone/APAP ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a188f02-629f-25cf-e063-6394a90a5766", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["857002"], "spl_set_id": ["446f01f0-2853-d104-e063-6394a90ae351"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (72189-649-20)", "package_ndc": "72189-649-20", "marketing_start_date": "20251125"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-649-30)", "package_ndc": "72189-649-30", "marketing_start_date": "20251125"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-649-60)", "package_ndc": "72189-649-60", "marketing_start_date": "20251125"}], "brand_name": "Hydrocodone/APAP", "product_id": "72189-649_4a188f02-629f-25cf-e063-6394a90a5766", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "72189-649", "dea_schedule": "CII", "generic_name": "Hydrocodone/APAP", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone/APAP", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA210211", "marketing_category": "ANDA", "marketing_start_date": "20251125", "listing_expiration_date": "20271231"}