promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

promethazine hydrochloride 6.25 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1854
Product ID 0121-1854_628c0c05-9610-4a8e-ae9b-f6aad47993d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040643
Listing Expiration 2026-12-31
Marketing Start 2025-08-07

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01211854
Hyphenated Format 0121-1854

Supplemental Identifiers

RxCUI
992432
UNII
R61ZEH7I1I

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 promethazine hydrochloride (source: ndc)
Generic Name promethazine hydrochloride (source: ndc)
Application Number ANDA040643 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0121-1854-16)
source: ndc

Packages (1)

0121-1854-16 473 mL in 1 BOTTLE (0121-1854-16)

Ingredients (1)

promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

Promethazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "628c0c05-9610-4a8e-ae9b-f6aad47993d6", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["7a186bcd-ab8c-4695-8289-4cd33bb551cf"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0121-1854-16)", "package_ndc": "0121-1854-16", "marketing_start_date": "20250807"}], "brand_name": "Promethazine Hydrochloride", "product_id": "0121-1854_628c0c05-9610-4a8e-ae9b-f6aad47993d6", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0121-1854", "generic_name": "Promethazine Hydrochloride", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040643", "marketing_category": "ANDA", "marketing_start_date": "20250807", "listing_expiration_date": "20261231"}