hydrocodone bitartrate and acetaminophen (72865-112)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

Labeler xlcare pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-112

Product ID 72865-112_fe42cdff-62f7-4209-b953-1f4d13ba4195

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211487

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2020-02-27

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72865112

Hyphenated Format 72865-112

Supplemental Identifiers

RxCUI

856999 857002 857005 857391

UPC

0372865111017 0372865112014 0372865109014 0372865110010

UNII

NO70W886KK 362O9ITL9D

Packaging Origin

Original Packager

true

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

100 TABLET in 1 BOTTLE (72865-112-01)
500 TABLET in 1 BOTTLE (72865-112-05)

source: ndc

Packages (2)

72865-112-01 100 TABLET in 1 BOTTLE (72865-112-01) 72865-112-05 500 TABLET in 1 BOTTLE (72865-112-05)

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": "fe42cdff-62f7-4209-b953-1f4d13ba4195", "openfda": {"upc": ["0372865111017", "0372865112014", "0372865109014", "0372865110010"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005", "857391"], "spl_set_id": ["73dea6de-20cb-4cef-b987-3ab2c64e5edb"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72865-112-01)", "package_ndc": "72865-112-01", "marketing_start_date": "20200227"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72865-112-05)", "package_ndc": "72865-112-05", "marketing_start_date": "20200227"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "72865-112_fe42cdff-62f7-4209-b953-1f4d13ba4195", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "72865-112", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "XLCare Pharmaceuticals, Inc.", "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": "20200227", "listing_expiration_date": "20261231"}