promethegan

Generic: promethazine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

promethazine hydrochloride 25 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-928
Product ID 55289-928_419b860e-68c0-f896-e063-6294a90aceb9
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 55289928
Hyphenated Format 55289-928

Supplemental Identifiers

UPC
0355289928041
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 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
  • 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-02)
  • 4 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-04)
  • 6 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-06)
  • 1 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-79)
source: ndc

Packages (4)

55289-928-02 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-02) 55289-928-04 4 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-04) 55289-928-06 6 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-06) 55289-928-79 1 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-79)

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": "419b860e-68c0-f896-e063-6294a90aceb9", "openfda": {"upc": ["0355289928041"], "unii": ["R61ZEH7I1I"], "spl_set_id": ["6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-02)", "package_ndc": "55289-928-02", "marketing_start_date": "20110713"}, {"sample": false, "description": "4 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-04)", "package_ndc": "55289-928-04", "marketing_start_date": "20110713"}, {"sample": false, "description": "6 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-06)", "package_ndc": "55289-928-06", "marketing_start_date": "20110713"}, {"sample": false, "description": "1 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-79)", "package_ndc": "55289-928-79", "marketing_start_date": "20110713"}], "brand_name": "PROMETHEGAN", "product_id": "55289-928_419b860e-68c0-f896-e063-6294a90aceb9", "dosage_form": "SUPPOSITORY", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "55289-928", "generic_name": "Promethazine Hydrochloride", "labeler_name": "PD-Rx 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"}