promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler a-s medication solutions
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

promethazine hydrochloride 6.25 mg/5mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6431
Product ID 50090-6431_20e7b205-90c4-4ac8-bc30-a55f38a1030d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091675
Listing Expiration 2026-12-31
Marketing Start 2012-06-08

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906431
Hyphenated Format 50090-6431

Supplemental Identifiers

RxCUI
992432
UNII
R61ZEH7I1I

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 ANDA091675 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (50090-6431-0)
source: ndc

Packages (1)

50090-6431-0 473 mL in 1 BOTTLE (50090-6431-0)

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": "20e7b205-90c4-4ac8-bc30-a55f38a1030d", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["c0a68671-407b-4840-9662-04f168cff1cb"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (50090-6431-0)", "package_ndc": "50090-6431-0", "marketing_start_date": "20230410"}], "brand_name": "promethazine hydrochloride", "product_id": "50090-6431_20e7b205-90c4-4ac8-bc30-a55f38a1030d", "dosage_form": "SYRUP", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "50090-6431", "generic_name": "promethazine hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "promethazine hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA091675", "marketing_category": "ANDA", "marketing_start_date": "20120608", "listing_expiration_date": "20261231"}