hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: genus lifesciences 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 genus lifesciences inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/15mL, hydrocodone bitartrate 7.5 mg/15mL

Manufacturer
Genus Lifesciences Inc.

Identifiers & Regulatory

Product NDC 64950-343
Product ID 64950-343_9ec83613-4c13-4ab7-a71d-c100d30c1e30
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040894
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2020-06-20

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64950343
Hyphenated Format 64950-343

Supplemental Identifiers

RxCUI
856940
UPC
0364950343168
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 ANDA040894 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 7.5 mg/15mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (64950-343-11)
  • 473 mL in 1 BOTTLE (64950-343-16)
source: ndc

Packages (2)

64950-343-11 118 mL in 1 BOTTLE (64950-343-11) 64950-343-16 473 mL in 1 BOTTLE (64950-343-16)

Ingredients (2)

acetaminophen (325 mg/15mL) hydrocodone bitartrate (7.5 mg/15mL)

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": "9ec83613-4c13-4ab7-a71d-c100d30c1e30", "openfda": {"upc": ["0364950343168"], "unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["856940"], "spl_set_id": ["26242cd7-1dbe-4ca4-88ca-5b98a6566ff9"], "manufacturer_name": ["Genus Lifesciences Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (64950-343-11)", "package_ndc": "64950-343-11", "marketing_start_date": "20200620"}, {"sample": false, "description": "473 mL in 1 BOTTLE (64950-343-16)", "package_ndc": "64950-343-16", "marketing_start_date": "20200620"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "64950-343_9ec83613-4c13-4ab7-a71d-c100d30c1e30", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "64950-343", "dea_schedule": "CII", "generic_name": "hydrocodone bitartrate and acetaminophen", "labeler_name": "Genus Lifesciences Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "7.5 mg/15mL"}], "application_number": "ANDA040894", "marketing_category": "ANDA", "marketing_start_date": "20200620", "listing_expiration_date": "20271231"}