hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: pai holdings, llc dba pai pharma
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 pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-2316
Product ID 0121-2316_1c5f2752-d5b9-4830-bc53-31c816f2bc09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040838
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2013-07-29

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01212316
Hyphenated Format 0121-2316

Supplemental Identifiers

RxCUI
856940
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 ANDA040838 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 7.5 mg/15mL
source: ndc
Packaging
  • 5 TRAY in 1 CASE (0121-2316-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

0121-2316-50 5 TRAY in 1 CASE (0121-2316-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE

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": "1c5f2752-d5b9-4830-bc53-31c816f2bc09", "openfda": {"unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856940"], "spl_set_id": ["c29b97e9-8097-4d87-a420-ccf5aec8274a"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 TRAY in 1 CASE (0121-2316-50)  / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE", "package_ndc": "0121-2316-50", "marketing_start_date": "20200521"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "0121-2316_1c5f2752-d5b9-4830-bc53-31c816f2bc09", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0121-2316", "dea_schedule": "CII", "generic_name": "HYDROCODONE BITARTRATE and ACETAMINOPHEN", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "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": "ANDA040838", "marketing_category": "ANDA", "marketing_start_date": "20130729", "listing_expiration_date": "20271231"}