hydrocodone bitartrate and acetaminophen (42806-111)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

Labeler epic pharma, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, hydrocodone bitartrate 5 mg/1

Manufacturer

Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-111

Product ID 42806-111_b3500a38-9dd0-4950-94f5-337c8f064e94

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203863

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2018-04-02

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806111

Hyphenated Format 42806-111

Supplemental Identifiers

RxCUI

856999 857002 857005

UPC

0342806113011 0342806111017

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 ANDA203863 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
5 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (42806-111-01)

source: ndc

Packages (1)

42806-111-01 100 TABLET in 1 BOTTLE (42806-111-01)

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": "b3500a38-9dd0-4950-94f5-337c8f064e94", "openfda": {"upc": ["0342806113011", "0342806111017"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["5179d4ab-6d57-4613-84fc-de3f6edd6a53"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42806-111-01)", "package_ndc": "42806-111-01", "marketing_start_date": "20180402"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "42806-111_b3500a38-9dd0-4950-94f5-337c8f064e94", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "42806-111", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Epic Pharma, LLC", "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": "ANDA203863", "marketing_category": "ANDA", "marketing_start_date": "20180402", "listing_expiration_date": "20261231"}