hydrocodone bitartrate and acetaminophen (72189-343)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

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 72189-343

Product ID 72189-343_2eaccf77-5ca1-97e7-e063-6394a90a7c39

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211487

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2022-03-30

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189343

Hyphenated Format 72189-343

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 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
5 mg/1

source: ndc

Packaging

8 TABLET in 1 BOTTLE (72189-343-08)
20 TABLET in 1 BOTTLE (72189-343-20)
30 TABLET in 1 BOTTLE (72189-343-30)
60 TABLET in 1 BOTTLE (72189-343-60)
120 TABLET in 1 BOTTLE (72189-343-72)
90 TABLET in 1 BOTTLE (72189-343-90)

source: ndc

Packages (6)

72189-343-08 8 TABLET in 1 BOTTLE (72189-343-08) 72189-343-20 20 TABLET in 1 BOTTLE (72189-343-20) 72189-343-30 30 TABLET in 1 BOTTLE (72189-343-30) 72189-343-60 60 TABLET in 1 BOTTLE (72189-343-60) 72189-343-72 120 TABLET in 1 BOTTLE (72189-343-72) 72189-343-90 90 TABLET in 1 BOTTLE (72189-343-90)

Ingredients (2)

acetaminophen (325 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": "2eaccf77-5ca1-97e7-e063-6394a90a7c39", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["857002"], "spl_set_id": ["db73b8ed-9747-6a49-e053-2a95a90a93a1"], "manufacturer_name": ["Direct Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "8 TABLET in 1 BOTTLE (72189-343-08)", "package_ndc": "72189-343-08", "marketing_start_date": "20220922"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (72189-343-20)", "package_ndc": "72189-343-20", "marketing_start_date": "20220330"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-343-30)", "package_ndc": "72189-343-30", "marketing_start_date": "20220330"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-343-60)", "package_ndc": "72189-343-60", "marketing_start_date": "20220330"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72189-343-72)", "package_ndc": "72189-343-72", "marketing_start_date": "20220330"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-343-90)", "package_ndc": "72189-343-90", "marketing_start_date": "20220330"}], "brand_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "product_id": "72189-343_2eaccf77-5ca1-97e7-e063-6394a90a7c39", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "72189-343", "dea_schedule": "CII", "generic_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "labeler_name": "Direct Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA211487", "marketing_category": "ANDA", "marketing_start_date": "20220330", "listing_expiration_date": "20261231"}