hydrocodone bitartrate and acetaminophen (27808-037)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

Labeler cranbury pharmaceuticals, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-037

Product ID 27808-037_cf89ef14-b1bb-4341-8911-892ce7d157c1

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202214

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2014-10-06

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27808037

Hyphenated Format 27808-037

Supplemental Identifiers

RxCUI

856999 857002 857005

UPC

0327808035011 0327808037015

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 ANDA202214 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE, PLASTIC (27808-037-01)
500 TABLET in 1 BOTTLE, PLASTIC (27808-037-02)
1000 TABLET in 1 BOTTLE, PLASTIC (27808-037-03)

source: ndc

Packages (3)

27808-037-01 100 TABLET in 1 BOTTLE, PLASTIC (27808-037-01) 27808-037-02 500 TABLET in 1 BOTTLE, PLASTIC (27808-037-02) 27808-037-03 1000 TABLET in 1 BOTTLE, PLASTIC (27808-037-03)

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": "cf89ef14-b1bb-4341-8911-892ce7d157c1", "openfda": {"upc": ["0327808035011", "0327808037015"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["d4caec6d-4af2-4f1c-9add-c0c948b83b16"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (27808-037-01)", "package_ndc": "27808-037-01", "marketing_start_date": "20141006"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (27808-037-02)", "package_ndc": "27808-037-02", "marketing_start_date": "20141006"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (27808-037-03)", "package_ndc": "27808-037-03", "marketing_start_date": "20141006"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "27808-037_cf89ef14-b1bb-4341-8911-892ce7d157c1", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "27808-037", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Cranbury Pharmaceuticals, 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": "10 mg/1"}], "application_number": "ANDA202214", "marketing_category": "ANDA", "marketing_start_date": "20141006", "listing_expiration_date": "20261231"}