hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: eywa pharma 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 eywa pharma inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Eywa Pharma Inc

Identifiers & Regulatory

Product NDC 71930-027
Product ID 71930-027_5ab6fc05-d708-4f00-9336-33a541bf0c87
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211023
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-04-08

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71930027
Hyphenated Format 71930-027

Supplemental Identifiers

RxCUI
856940
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 ANDA211023 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 7.5 mg/15mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (71930-027-43)
source: ndc

Packages (1)

71930-027-43 473 mL in 1 BOTTLE (71930-027-43)

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": "5ab6fc05-d708-4f00-9336-33a541bf0c87", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["856940"], "spl_set_id": ["adb37532-aa19-48a2-95a1-8c92a6ce8651"], "manufacturer_name": ["Eywa Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (71930-027-43)", "package_ndc": "71930-027-43", "marketing_start_date": "20190408"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "71930-027_5ab6fc05-d708-4f00-9336-33a541bf0c87", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "71930-027", "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/15mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "7.5 mg/15mL"}], "application_number": "ANDA211023", "marketing_category": "ANDA", "marketing_start_date": "20190408", "listing_expiration_date": "20261231"}