hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: cranbury pharmaceuticals, 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 cranbury pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, hydrocodone bitartrate 5 mg/1

Manufacturer
Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-114
Product ID 27808-114_b87bebc7-651b-4b88-8921-cfddb4265559
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202214
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-04-07

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27808114
Hyphenated Format 27808-114

Supplemental Identifiers

RxCUI
856980 856987 856992
UPC
0327808115010 0327808114013 0327808116017
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
  • 300 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (27808-114-01)
  • 500 TABLET in 1 BOTTLE (27808-114-02)
source: ndc

Packages (2)

27808-114-01 100 TABLET in 1 BOTTLE, PLASTIC (27808-114-01) 27808-114-02 500 TABLET in 1 BOTTLE (27808-114-02)

Ingredients (2)

acetaminophen (300 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": "b87bebc7-651b-4b88-8921-cfddb4265559", "openfda": {"upc": ["0327808115010", "0327808114013", "0327808116017"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856980", "856987", "856992"], "spl_set_id": ["d8fe4ae4-bd19-42eb-b74d-f302b3f914ee"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (27808-114-01)", "package_ndc": "27808-114-01", "marketing_start_date": "20160407"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (27808-114-02)", "package_ndc": "27808-114-02", "marketing_start_date": "20160407"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "27808-114_b87bebc7-651b-4b88-8921-cfddb4265559", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "27808-114", "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": "300 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA202214", "marketing_category": "ANDA", "marketing_start_date": "20160407", "listing_expiration_date": "20261231"}