promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler asclemed usa, inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

promethazine hydrochloride 12.5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-388
Product ID 76420-388_36f60cbe-813d-cfa8-e063-6294a90a0b0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040500
Listing Expiration 2026-12-31
Marketing Start 2006-06-27

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420388
Hyphenated Format 76420-388

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
  • 12.5 mg/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (76420-388-30) / 1 SUPPOSITORY in 1 BLISTER PACK
source: ndc

Packages (1)

76420-388-30 12 BLISTER PACK in 1 CARTON (76420-388-30) / 1 SUPPOSITORY in 1 BLISTER PACK

Ingredients (1)

promethazine hydrochloride (12.5 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": "36f60cbe-813d-cfa8-e063-6294a90a0b0a", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992441", "992454"], "spl_set_id": ["1b1cee64-c0b5-4da6-92d0-1769350a5181"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (76420-388-30)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "76420-388-30", "marketing_start_date": "20250607"}], "brand_name": "Promethazine Hydrochloride", "product_id": "76420-388_36f60cbe-813d-cfa8-e063-6294a90a0b0a", "dosage_form": "SUPPOSITORY", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "76420-388", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA040500", "marketing_category": "ANDA", "marketing_start_date": "20060627", "listing_expiration_date": "20261231"}