hydrocodone bitartrate and acetaminophen (43386-353)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

Labeler lupin pharmaceuticals,inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 300 mg/1, hydrocodone bitartrate 10 mg/1

Manufacturer

Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-353

Product ID 43386-353_cc982f78-de8c-4384-9f43-ffad4169abdd

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA206142

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2016-11-14

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386353

Hyphenated Format 43386-353

Supplemental Identifiers

RxCUI

856980 856987 856992

UPC

0343386351039 0343386352036 0343386353057

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 ANDA206142 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (43386-353-01)
500 TABLET in 1 BOTTLE (43386-353-05)

source: ndc

Packages (2)

43386-353-01 100 TABLET in 1 BOTTLE (43386-353-01) 43386-353-05 500 TABLET in 1 BOTTLE (43386-353-05)

Ingredients (2)

acetaminophen (300 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": "cc982f78-de8c-4384-9f43-ffad4169abdd", "openfda": {"upc": ["0343386351039", "0343386352036", "0343386353057"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856980", "856987", "856992"], "spl_set_id": ["48cc1378-ffab-4645-95bb-a05d78066575"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (43386-353-01)", "package_ndc": "43386-353-01", "marketing_start_date": "20161114"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43386-353-05)", "package_ndc": "43386-353-05", "marketing_start_date": "20161114"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "43386-353_cc982f78-de8c-4384-9f43-ffad4169abdd", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "43386-353", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA206142", "marketing_category": "ANDA", "marketing_start_date": "20161114", "listing_expiration_date": "20261231"}