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 SUPPOSITORY
Routes
RECTAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-2747
Product ID 50090-2747_341bc00d-005a-4914-ba57-483d54081cdb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040500
Listing Expiration 2026-12-31
Marketing Start 2006-05-17

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500902747
Hyphenated Format 50090-2747

Supplemental Identifiers

RxCUI
992441 992454
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 ANDA040500 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (50090-2747-1) / 1 SUPPOSITORY in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (50090-2747-2) / 1 SUPPOSITORY in 1 BLISTER PACK
source: ndc

Packages (2)

50090-2747-1 4 BLISTER PACK in 1 CARTON (50090-2747-1) / 1 SUPPOSITORY in 1 BLISTER PACK 50090-2747-2 6 BLISTER PACK in 1 CARTON (50090-2747-2) / 1 SUPPOSITORY in 1 BLISTER PACK

Ingredients (1)

promethazine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Promethazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "341bc00d-005a-4914-ba57-483d54081cdb", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992441", "992454"], "spl_set_id": ["46b869e2-9305-43ae-bb15-919a6d09b6ff"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (50090-2747-1)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "50090-2747-1", "marketing_start_date": "20170105"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (50090-2747-2)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "50090-2747-2", "marketing_start_date": "20170111"}], "brand_name": "Promethazine Hydrochloride", "product_id": "50090-2747_341bc00d-005a-4914-ba57-483d54081cdb", "dosage_form": "SUPPOSITORY", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "50090-2747", "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": "25 mg/1"}], "application_number": "ANDA040500", "marketing_category": "ANDA", "marketing_start_date": "20060517", "listing_expiration_date": "20261231"}