promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 12.5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-040
Product ID 65841-040_800e2d40-d3af-43a0-9ea0-41e2d1d0e8b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040596
Listing Expiration 2026-12-31
Marketing Start 2005-12-14

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65841040
Hyphenated Format 65841-040

Supplemental Identifiers

RxCUI
992438 992447 992475
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 ANDA040596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65841-040-01)
  • 500 TABLET in 1 BOTTLE (65841-040-05)
  • 1000 TABLET in 1 BOTTLE (65841-040-10)
source: ndc

Packages (3)

65841-040-01 100 TABLET in 1 BOTTLE (65841-040-01) 65841-040-05 500 TABLET in 1 BOTTLE (65841-040-05) 65841-040-10 1000 TABLET in 1 BOTTLE (65841-040-10)

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": ["ORAL"], "spl_id": "800e2d40-d3af-43a0-9ea0-41e2d1d0e8b5", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992438", "992447", "992475"], "spl_set_id": ["4eaa8291-9cde-4205-857b-925ea8d618ba"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65841-040-01)", "package_ndc": "65841-040-01", "marketing_start_date": "20051214"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65841-040-05)", "package_ndc": "65841-040-05", "marketing_start_date": "20051214"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65841-040-10)", "package_ndc": "65841-040-10", "marketing_start_date": "20051214"}], "brand_name": "Promethazine Hydrochloride", "product_id": "65841-040_800e2d40-d3af-43a0-9ea0-41e2d1d0e8b5", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "65841-040", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA040596", "marketing_category": "ANDA", "marketing_start_date": "20051214", "listing_expiration_date": "20261231"}