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 72189-407
Product ID 72189-407_2c4cf13b-5454-0aa9-e063-6394a90ac235
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040409
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-12-28

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189407
Hyphenated Format 72189-407

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 ANDA040409 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-407-30)
  • 60 TABLET in 1 BOTTLE (72189-407-60)
  • 120 TABLET in 1 BOTTLE (72189-407-72)
  • 90 TABLET in 1 BOTTLE (72189-407-90)
source: ndc

Packages (4)

72189-407-30 30 TABLET in 1 BOTTLE (72189-407-30) 72189-407-60 60 TABLET in 1 BOTTLE (72189-407-60) 72189-407-72 120 TABLET in 1 BOTTLE (72189-407-72) 72189-407-90 90 TABLET in 1 BOTTLE (72189-407-90)

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": "2c4cf13b-5454-0aa9-e063-6394a90ac235", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["857002"], "spl_set_id": ["f0e66441-668a-7ab8-e053-2995a90aba4f"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-407-30)", "package_ndc": "72189-407-30", "marketing_start_date": "20221228"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-407-60)", "package_ndc": "72189-407-60", "marketing_start_date": "20221228"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72189-407-72)", "package_ndc": "72189-407-72", "marketing_start_date": "20221228"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-407-90)", "package_ndc": "72189-407-90", "marketing_start_date": "20221228"}], "brand_name": "Hydrocodone/APAP", "product_id": "72189-407_2c4cf13b-5454-0aa9-e063-6394a90ac235", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "72189-407", "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": "ANDA040409", "marketing_category": "ANDA", "marketing_start_date": "20221228", "listing_expiration_date": "20261231"}