hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: upsher-smith laboratories, 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 upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0245-0410
Product ID 0245-0410_39e7eaec-9677-7a63-e063-6394a90a520e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206484
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-03-27

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02450410
Hyphenated Format 0245-0410

Supplemental Identifiers

RxCUI
856999 857002 857005
UNII
NO70W886KK 362O9ITL9D

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 ANDA206484 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0245-0410-01) / 1 TABLET in 1 BLISTER PACK (0245-0410-89)
  • 100 TABLET in 1 BOTTLE (0245-0410-11)
  • 500 TABLET in 1 BOTTLE (0245-0410-50)
source: ndc

Packages (3)

0245-0410-01 100 BLISTER PACK in 1 CARTON (0245-0410-01) / 1 TABLET in 1 BLISTER PACK (0245-0410-89) 0245-0410-11 100 TABLET in 1 BOTTLE (0245-0410-11) 0245-0410-50 500 TABLET in 1 BOTTLE (0245-0410-50)

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": "39e7eaec-9677-7a63-e063-6394a90a520e", "openfda": {"unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["3aa0b733-b58f-46bd-8e76-37ddf1dc3356"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0245-0410-01)  / 1 TABLET in 1 BLISTER PACK (0245-0410-89)", "package_ndc": "0245-0410-01", "marketing_start_date": "20170327"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (0245-0410-11)", "package_ndc": "0245-0410-11", "marketing_start_date": "20170327"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0245-0410-50)", "package_ndc": "0245-0410-50", "marketing_start_date": "20170327"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "0245-0410_39e7eaec-9677-7a63-e063-6394a90a520e", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0245-0410", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Upsher-Smith Laboratories, 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": "ANDA206484", "marketing_category": "ANDA", "marketing_start_date": "20170327", "listing_expiration_date": "20261231"}