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 SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/15mL, hydrocodone bitartrate 10 mg/15mL

Manufacturer
Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-130
Product ID 27808-130_5b4bd464-17c3-42af-a519-ef795299e692
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201295
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2021-12-30

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27808130
Hyphenated Format 27808-130

Supplemental Identifiers

RxCUI
1044427
UPC
0327808130013
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 ANDA201295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/15mL
  • 10 mg/15mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (27808-130-01)
source: ndc

Packages (1)

27808-130-01 473 mL in 1 BOTTLE, PLASTIC (27808-130-01)

Ingredients (2)

acetaminophen (300 mg/15mL) hydrocodone bitartrate (10 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": "5b4bd464-17c3-42af-a519-ef795299e692", "openfda": {"upc": ["0327808130013"], "unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["1044427"], "spl_set_id": ["93b6dfdf-ba6e-4ea6-ab85-5ac121e33101"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (27808-130-01)", "package_ndc": "27808-130-01", "marketing_start_date": "20221230"}], "brand_name": "hydrocodone bitartrate and acetaminophen", "product_id": "27808-130_5b4bd464-17c3-42af-a519-ef795299e692", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "27808-130", "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/15mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/15mL"}], "application_number": "ANDA201295", "marketing_category": "ANDA", "marketing_start_date": "20211230", "listing_expiration_date": "20271231"}