melphalan hydrochloride

Generic: melphalan hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name melphalan hydrochloride
Generic Name melphalan hydrochloride
Labeler gland pharma limited
Dosage Form KIT
Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-259
Product ID 68083-259_c1a5c2ee-7acc-44f6-8e95-534a2d88e223
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209826
Listing Expiration 2026-12-31
Marketing Start 2019-06-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083259
Hyphenated Format 68083-259

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)

Resolved Composition

Strengths
  • 50 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (68083-259-01) * 10 mL in 1 VIAL, SINGLE-USE (68083-261-01) * 10 mL in 1 VIAL, SINGLE-DOSE (68083-260-01)
source: ndc

Packages (1)

68083-259-01 1 KIT in 1 CARTON (68083-259-01) * 10 mL in 1 VIAL, SINGLE-USE (68083-261-01) * 10 mL in 1 VIAL, SINGLE-DOSE (68083-260-01)

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 
{"spl_id": "c1a5c2ee-7acc-44f6-8e95-534a2d88e223", "openfda": {"rxcui": ["311487"], "spl_set_id": ["ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (68083-259-01)  *  10 mL in 1 VIAL, SINGLE-USE (68083-261-01)  *  10 mL in 1 VIAL, SINGLE-DOSE (68083-260-01)", "package_ndc": "68083-259-01", "marketing_start_date": "20190610"}], "brand_name": "Melphalan hydrochloride", "product_id": "68083-259_c1a5c2ee-7acc-44f6-8e95-534a2d88e223", "dosage_form": "KIT", "product_ndc": "68083-259", "generic_name": "Melphalan hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Melphalan hydrochloride", "application_number": "ANDA209826", "marketing_category": "ANDA", "marketing_start_date": "20190610", "listing_expiration_date": "20261231"}