melphalan hydrochloride

Generic: melphalan hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name melphalan hydrochloride
Generic Name melphalan hydrochloride
Labeler sagent pharmaceuticals
Dosage Form KIT
Routes
INTRAVENOUS
Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-258
Product ID 25021-258_6c52e5c7-4b97-451c-aacd-b43046fd164a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209826
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021258
Hyphenated Format 25021-258

Supplemental Identifiers

RxCUI
311487

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 melphalan hydrochloride (source: ndc)
Generic Name melphalan hydrochloride (source: ndc)
Application Number ANDA209826 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg
  • 10 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (25021-258-61) * 10 mL in 1 VIAL (25021-256-10) * 10 mL in 1 VIAL (25021-257-10)
source: ndc

Packages (1)

25021-258-61 1 KIT in 1 CARTON (25021-258-61) * 10 mL in 1 VIAL (25021-256-10) * 10 mL in 1 VIAL (25021-257-10)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Melphalan Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6c52e5c7-4b97-451c-aacd-b43046fd164a", "openfda": {"rxcui": ["311487"], "spl_set_id": ["35f3d9fe-3c2f-4362-9d40-cdab014cac38"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (25021-258-61)  *  10 mL in 1 VIAL (25021-256-10)  *  10 mL in 1 VIAL (25021-257-10)", "package_ndc": "25021-258-61", "marketing_start_date": "20240401"}], "brand_name": "Melphalan Hydrochloride", "product_id": "25021-258_6c52e5c7-4b97-451c-aacd-b43046fd164a", "dosage_form": "KIT", "product_ndc": "25021-258", "generic_name": "Melphalan Hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Melphalan Hydrochloride", "application_number": "ANDA209826", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}