hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: sun pharmaceutical industries, inc.
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 sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-497
Product ID 63304-497_4f875c7a-4454-45a2-bf55-fcc2932c51db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040826
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-07-31

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304497
Hyphenated Format 63304-497

Supplemental Identifiers

RxCUI
856999
UPC
0363304497014
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 ANDA040826 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (63304-497-01)
  • 10 TABLET in 1 BOTTLE (63304-497-03)
  • 500 TABLET in 1 BOTTLE (63304-497-05)
  • 1000 TABLET in 1 BOTTLE (63304-497-10)
  • 10 BLISTER PACK in 1 CARTON (63304-497-69) / 1 TABLET in 1 BLISTER PACK (63304-497-11)
source: ndc

Packages (5)

63304-497-01 100 TABLET in 1 BOTTLE (63304-497-01) 63304-497-03 10 TABLET in 1 BOTTLE (63304-497-03) 63304-497-05 500 TABLET in 1 BOTTLE (63304-497-05) 63304-497-10 1000 TABLET in 1 BOTTLE (63304-497-10) 63304-497-69 10 BLISTER PACK in 1 CARTON (63304-497-69) / 1 TABLET in 1 BLISTER PACK (63304-497-11)

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": "4f875c7a-4454-45a2-bf55-fcc2932c51db", "openfda": {"upc": ["0363304497014"], "unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["856999"], "spl_set_id": ["6e153073-ca78-481e-9e9c-0365ee3f3d59"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (63304-497-01)", "package_ndc": "63304-497-01", "marketing_start_date": "20180731"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (63304-497-03)", "package_ndc": "63304-497-03", "marketing_start_date": "20180731"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (63304-497-05)", "package_ndc": "63304-497-05", "marketing_start_date": "20180731"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (63304-497-10)", "package_ndc": "63304-497-10", "marketing_start_date": "20180731"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (63304-497-69)  / 1 TABLET in 1 BLISTER PACK (63304-497-11)", "package_ndc": "63304-497-69", "marketing_start_date": "20180731"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "63304-497_4f875c7a-4454-45a2-bf55-fcc2932c51db", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "63304-497", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Sun Pharmaceutical Industries, 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": "ANDA040826", "marketing_category": "ANDA", "marketing_start_date": "20180731", "listing_expiration_date": "20261231"}