hydrocodone bitartrate and acetaminophen (72189-348)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

Labeler directrx

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

DirectRx

Identifiers & Regulatory

Product NDC 72189-348

Product ID 72189-348_2eacd5a8-4f00-9d9b-e063-6394a90a0f74

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211487

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2022-04-26

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189348

Hyphenated Format 72189-348

Supplemental Identifiers

RxCUI

856999

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 ANDA211487 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

20 TABLET in 1 BOTTLE (72189-348-20)
30 TABLET in 1 BOTTLE (72189-348-30)
60 TABLET in 1 BOTTLE (72189-348-60)
120 TABLET in 1 BOTTLE (72189-348-72)
90 TABLET in 1 BOTTLE (72189-348-90)

source: ndc

Packages (5)

72189-348-20 20 TABLET in 1 BOTTLE (72189-348-20) 72189-348-30 30 TABLET in 1 BOTTLE (72189-348-30) 72189-348-60 60 TABLET in 1 BOTTLE (72189-348-60) 72189-348-72 120 TABLET in 1 BOTTLE (72189-348-72) 72189-348-90 90 TABLET in 1 BOTTLE (72189-348-90)

Ingredients (2)

acetaminophen (325 mg/1) hydrocodone bitartrate (10 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": "2eacd5a8-4f00-9d9b-e063-6394a90a0f74", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["856999"], "spl_set_id": ["dd934235-3b2a-51ca-e053-2995a90a0016"], "manufacturer_name": ["DirectRx"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (72189-348-20)", "package_ndc": "72189-348-20", "marketing_start_date": "20220426"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-348-30)", "package_ndc": "72189-348-30", "marketing_start_date": "20220426"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-348-60)", "package_ndc": "72189-348-60", "marketing_start_date": "20220426"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72189-348-72)", "package_ndc": "72189-348-72", "marketing_start_date": "20220426"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-348-90)", "package_ndc": "72189-348-90", "marketing_start_date": "20220426"}], "brand_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "product_id": "72189-348_2eacd5a8-4f00-9d9b-e063-6394a90a0f74", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "72189-348", "dea_schedule": "CII", "generic_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "labeler_name": "DirectRx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA211487", "marketing_category": "ANDA", "marketing_start_date": "20220426", "listing_expiration_date": "20261231"}