promethegan

Generic: promethazine hydrochloride

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethegan
Generic Name promethazine hydrochloride
Labeler cosette pharmaceuticals, inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0526
Product ID 0713-0526_0b622b7b-a45f-eab0-e063-6394a90a0c0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040428
Listing Expiration 2026-12-31
Marketing Start 2002-02-28

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130526
Hyphenated Format 0713-0526

Supplemental Identifiers

RxCUI
992441 992445 992454 992459
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 promethegan (source: ndc)
Generic Name promethazine hydrochloride (source: ndc)
Application Number ANDA040428 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 SUPPOSITORY in 1 BOX (0713-0526-10)
  • 12 SUPPOSITORY in 1 BOX (0713-0526-12)
source: ndc

Packages (2)

0713-0526-10 1000 SUPPOSITORY in 1 BOX (0713-0526-10) 0713-0526-12 12 SUPPOSITORY in 1 BOX (0713-0526-12)

Ingredients (1)

promethazine hydrochloride (25 mg/1)

Linked Drug Pages (1)

PROMETHEGAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "0b622b7b-a45f-eab0-e063-6394a90a0c0a", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992441", "992445", "992454", "992459"], "spl_set_id": ["5f079815-f48b-8b21-2130-7f791d967c9a"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 SUPPOSITORY in 1 BOX (0713-0526-10)", "package_ndc": "0713-0526-10", "marketing_start_date": "20020228"}, {"sample": false, "description": "12 SUPPOSITORY in 1 BOX (0713-0526-12)", "package_ndc": "0713-0526-12", "marketing_start_date": "20020228"}], "brand_name": "PROMETHEGAN", "product_id": "0713-0526_0b622b7b-a45f-eab0-e063-6394a90a0c0a", "dosage_form": "SUPPOSITORY", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0713-0526", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROMETHEGAN", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040428", "marketing_category": "ANDA", "marketing_start_date": "20020228", "listing_expiration_date": "20261231"}