hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen
Generic Name hydrocodone bitartrate and acetaminophen
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-109
Product ID 53746-109_a83ec256-95c3-4b3a-b911-2eb415308a4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040736
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2010-01-18

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746109
Hyphenated Format 53746-109

Supplemental Identifiers

RxCUI
857002
UPC
0353746109101 0353746109019
UNII
362O9ITL9D NO70W886KK

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 ANDA040736 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-109-01)
  • 500 TABLET in 1 BOTTLE (53746-109-05)
  • 1000 TABLET in 1 BOTTLE (53746-109-10)
source: ndc

Packages (3)

53746-109-01 100 TABLET in 1 BOTTLE (53746-109-01) 53746-109-05 500 TABLET in 1 BOTTLE (53746-109-05) 53746-109-10 1000 TABLET in 1 BOTTLE (53746-109-10)

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": "a83ec256-95c3-4b3a-b911-2eb415308a4d", "openfda": {"upc": ["0353746109101", "0353746109019"], "unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["857002"], "spl_set_id": ["62be4147-6a72-49e5-9338-10887c65a93a"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-109-01)", "package_ndc": "53746-109-01", "marketing_start_date": "20100118"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-109-05)", "package_ndc": "53746-109-05", "marketing_start_date": "20100118"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-109-10)", "package_ndc": "53746-109-10", "marketing_start_date": "20100118"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "53746-109_a83ec256-95c3-4b3a-b911-2eb415308a4d", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "53746-109", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Amneal Pharmaceuticals of New York 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": "ANDA040736", "marketing_category": "ANDA", "marketing_start_date": "20100118", "listing_expiration_date": "20261231"}