hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: amneal pharmaceuticals 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 llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, hydrocodone bitartrate 7.5 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-115
Product ID 65162-115_1b44ad7b-ee24-499c-9814-24a95779a97f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040746
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-06-30

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162115
Hyphenated Format 65162-115

Supplemental Identifiers

RxCUI
857005
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 ANDA040746 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 7.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-115-03)
  • 100 TABLET in 1 BOTTLE (65162-115-10)
  • 1000 TABLET in 1 BOTTLE (65162-115-11)
  • 500 TABLET in 1 BOTTLE (65162-115-50)
source: ndc

Packages (4)

65162-115-03 30 TABLET in 1 BOTTLE (65162-115-03) 65162-115-10 100 TABLET in 1 BOTTLE (65162-115-10) 65162-115-11 1000 TABLET in 1 BOTTLE (65162-115-11) 65162-115-50 500 TABLET in 1 BOTTLE (65162-115-50)

Ingredients (2)

acetaminophen (325 mg/1) hydrocodone bitartrate (7.5 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": "1b44ad7b-ee24-499c-9814-24a95779a97f", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["857005"], "spl_set_id": ["e23d135c-7aea-405a-804e-5c4f82179e96"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-115-03)", "package_ndc": "65162-115-03", "marketing_start_date": "20160630"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (65162-115-10)", "package_ndc": "65162-115-10", "marketing_start_date": "20160630"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-115-11)", "package_ndc": "65162-115-11", "marketing_start_date": "20160630"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-115-50)", "package_ndc": "65162-115-50", "marketing_start_date": "20160630"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "65162-115_1b44ad7b-ee24-499c-9814-24a95779a97f", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "65162-115", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Amneal Pharmaceuticals 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": "7.5 mg/1"}], "application_number": "ANDA040746", "marketing_category": "ANDA", "marketing_start_date": "20160630", "listing_expiration_date": "20261231"}