hydrocodone bitartrate and acetaminophen (71930-021)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

Labeler eywa pharma inc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Eywa Pharma Inc

Identifiers & Regulatory

Product NDC 71930-021

Product ID 71930-021_a9e9366b-97c9-4d86-962f-b3f8e3338fa9

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210211

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2018-07-13

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71930021

Hyphenated Format 71930-021

Supplemental Identifiers

RxCUI

856999 857002 857005

UPC

0371930019524 0371930020124 0371930021527 0371930021138 0371930020520 0371930021121 0371930020131 0371930019128

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 ANDA210211 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (71930-021-12)
1000 TABLET in 1 BOTTLE (71930-021-13)
500 TABLET in 1 BOTTLE (71930-021-52)

source: ndc

Packages (3)

71930-021-12 100 TABLET in 1 BOTTLE (71930-021-12) 71930-021-13 1000 TABLET in 1 BOTTLE (71930-021-13) 71930-021-52 500 TABLET in 1 BOTTLE (71930-021-52)

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": "a9e9366b-97c9-4d86-962f-b3f8e3338fa9", "openfda": {"upc": ["0371930019524", "0371930020124", "0371930021527", "0371930021138", "0371930020520", "0371930021121", "0371930020131", "0371930019128"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["fcd2b59e-8087-475e-9e6b-911bd846ea96"], "manufacturer_name": ["Eywa Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71930-021-12)", "package_ndc": "71930-021-12", "marketing_start_date": "20180713"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (71930-021-13)", "package_ndc": "71930-021-13", "marketing_start_date": "20221006"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (71930-021-52)", "package_ndc": "71930-021-52", "marketing_start_date": "20180713"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "71930-021_a9e9366b-97c9-4d86-962f-b3f8e3338fa9", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "71930-021", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Eywa Pharma 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": "ANDA210211", "marketing_category": "ANDA", "marketing_start_date": "20180713", "listing_expiration_date": "20261231"}