promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-041
Product ID 68382-041_d461a206-0842-428f-ad9b-a4aac8193fe9
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 68382041
Hyphenated Format 68382-041

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
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-041-01)
  • 500 TABLET in 1 BOTTLE (68382-041-05)
  • 1000 TABLET in 1 BOTTLE (68382-041-10)
source: ndc

Packages (3)

68382-041-01 100 TABLET in 1 BOTTLE (68382-041-01) 68382-041-05 500 TABLET in 1 BOTTLE (68382-041-05) 68382-041-10 1000 TABLET in 1 BOTTLE (68382-041-10)

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": "d461a206-0842-428f-ad9b-a4aac8193fe9", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992438", "992447", "992475"], "spl_set_id": ["c0c0d4f0-8396-485b-a585-71df01491f6f"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-041-01)", "package_ndc": "68382-041-01", "marketing_start_date": "20051214"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-041-05)", "package_ndc": "68382-041-05", "marketing_start_date": "20051214"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-041-10)", "package_ndc": "68382-041-10", "marketing_start_date": "20051214"}], "brand_name": "Promethazine Hydrochloride", "product_id": "68382-041_d461a206-0842-428f-ad9b-a4aac8193fe9", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "68382-041", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040596", "marketing_category": "ANDA", "marketing_start_date": "20051214", "listing_expiration_date": "20261231"}