promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-3373
Product ID 55154-3373_6b7956e8-7bdc-4b48-9779-0b655c46e8ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091179
Listing Expiration 2026-12-31
Marketing Start 2024-07-02

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551543373
Hyphenated Format 55154-3373

Supplemental Identifiers

RxCUI
992447
UPC
0055154337304
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 ANDA091179 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-3373-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

55154-3373-0 10 BLISTER PACK in 1 BAG (55154-3373-0) / 1 TABLET 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": ["ORAL"], "spl_id": "6b7956e8-7bdc-4b48-9779-0b655c46e8ca", "openfda": {"upc": ["0055154337304"], "unii": ["R61ZEH7I1I"], "rxcui": ["992447"], "spl_set_id": ["e16238dc-9292-49ac-b80f-8afeccb88bc5"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-3373-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-3373-0", "marketing_start_date": "20240702"}], "brand_name": "Promethazine Hydrochloride", "product_id": "55154-3373_6b7956e8-7bdc-4b48-9779-0b655c46e8ca", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "55154-3373", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA091179", "marketing_category": "ANDA", "marketing_start_date": "20240702", "listing_expiration_date": "20261231"}