hydrocodone bitartrate and homatropine methylbromide

Generic: hydrocodone bitartrate and homatropine methylbromide

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and homatropine methylbromide
Generic Name hydrocodone bitartrate and homatropine methylbromide
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

homatropine methylbromide 1.5 mg/5mL, hydrocodone bitartrate 5 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1036
Product ID 0121-1036_3b3068f2-238d-46b3-b80d-a0ae90142908
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA005213
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-08-05

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01211036
Hyphenated Format 0121-1036

Supplemental Identifiers

RxCUI
992668
UNII
68JRS2HC1C NO70W886KK

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 homatropine methylbromide (source: ndc)
Generic Name hydrocodone bitartrate and homatropine methylbromide (source: ndc)
Application Number NDA005213 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05)
source: ndc

Packages (1)

0121-1036-40 4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05)

Ingredients (2)

homatropine methylbromide (1.5 mg/5mL) hydrocodone bitartrate (5 mg/5mL)

Linked Drug Pages (1)

Hydrocodone Bitartrate and Homatropine Methylbromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b3068f2-238d-46b3-b80d-a0ae90142908", "openfda": {"unii": ["68JRS2HC1C", "NO70W886KK"], "rxcui": ["992668"], "spl_set_id": ["71319a6f-aaf4-4bc5-8b40-a16c6f139be6"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TRAY in 1 CASE (0121-1036-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05)", "package_ndc": "0121-1036-40", "marketing_start_date": "20240805"}], "brand_name": "Hydrocodone Bitartrate and Homatropine Methylbromide", "product_id": "0121-1036_3b3068f2-238d-46b3-b80d-a0ae90142908", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0121-1036", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Homatropine Methylbromide", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Homatropine Methylbromide", "active_ingredients": [{"name": "HOMATROPINE METHYLBROMIDE", "strength": "1.5 mg/5mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/5mL"}], "application_number": "NDA005213", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240805", "listing_expiration_date": "20261231"}