hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: avpak
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 avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-400
Product ID 50268-400_47e5550b-f34a-dda4-e063-6294a90affee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040746
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2016-10-28

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268400
Hyphenated Format 50268-400

Supplemental Identifiers

RxCUI
857005
UNII
362O9ITL9D NO70W886KK

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
  • 50 BLISTER PACK in 1 BOX (50268-400-15) / 1 TABLET in 1 BLISTER PACK (50268-400-11)
source: ndc

Packages (1)

50268-400-15 50 BLISTER PACK in 1 BOX (50268-400-15) / 1 TABLET in 1 BLISTER PACK (50268-400-11)

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": "47e5550b-f34a-dda4-e063-6294a90affee", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["857005"], "spl_set_id": ["678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc3"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-400-15)  / 1 TABLET in 1 BLISTER PACK (50268-400-11)", "package_ndc": "50268-400-15", "marketing_start_date": "20161028"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "50268-400_47e5550b-f34a-dda4-e063-6294a90affee", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "50268-400", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "AvPAK", "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": "20161028", "listing_expiration_date": "20271231"}