norco

Generic: hydrocodone/apap

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-399
Product ID 72189-399_2c4ce870-c59f-df00-e063-6394a90a9011
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040400
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-11-23

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189399
Hyphenated Format 72189-399

Supplemental Identifiers

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 norco (source: ndc)
Generic Name hydrocodone/apap (source: ndc)
Application Number ANDA040400 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-399-30)
  • 60 TABLET in 1 BOTTLE (72189-399-60)
  • 120 TABLET in 1 BOTTLE (72189-399-72)
  • 90 TABLET in 1 BOTTLE (72189-399-90)
source: ndc

Packages (4)

Ingredients (2)

acetaminophen (325 mg/1) hydrocodone bitartrate (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2c4ce870-c59f-df00-e063-6394a90a9011", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "spl_set_id": ["ee248dfd-7aa7-7dcc-e053-2995a90af19f"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-399-30)", "package_ndc": "72189-399-30", "marketing_start_date": "20221123"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-399-60)", "package_ndc": "72189-399-60", "marketing_start_date": "20221123"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72189-399-72)", "package_ndc": "72189-399-72", "marketing_start_date": "20221123"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-399-90)", "package_ndc": "72189-399-90", "marketing_start_date": "20221123"}], "brand_name": "Norco", "product_id": "72189-399_2c4ce870-c59f-df00-e063-6394a90a9011", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "72189-399", "dea_schedule": "CII", "generic_name": "Hydrocodone/APAP", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norco", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA040400", "marketing_category": "ANDA", "marketing_start_date": "20221123", "listing_expiration_date": "20261231"}