melphalan hydrochloride

Generic: melphalan hydrochloride

Labeler: avenacy inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name melphalan hydrochloride
Generic Name melphalan hydrochloride
Labeler avenacy inc.
Dosage Form KIT
Routes
INTRAVENOUS
Manufacturer
Avenacy Inc.

Identifiers & Regulatory

Product NDC 83634-202
Product ID 83634-202_47da36c6-67e2-44c7-93d8-4f236abb73e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211463
Listing Expiration 2026-12-31
Marketing Start 2023-12-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83634202
Hyphenated Format 83634-202

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 ANDA211463 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg
  • 10 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (83634-202-61) * 15 mL in 1 VIAL, SINGLE-DOSE (83634-200-15) * 10 mL in 1 VIAL, SINGLE-USE (83634-201-10)
source: ndc

Packages (1)

83634-202-61 1 KIT in 1 CARTON (83634-202-61) * 15 mL in 1 VIAL, SINGLE-DOSE (83634-200-15) * 10 mL in 1 VIAL, SINGLE-USE (83634-201-10)

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": "47da36c6-67e2-44c7-93d8-4f236abb73e7", "openfda": {"rxcui": ["311487"], "spl_set_id": ["8edd78a9-d762-4578-a610-28d6595f4bf3"], "manufacturer_name": ["Avenacy Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (83634-202-61)  *  15 mL in 1 VIAL, SINGLE-DOSE (83634-200-15)  *  10 mL in 1 VIAL, SINGLE-USE (83634-201-10)", "package_ndc": "83634-202-61", "marketing_start_date": "20231218"}], "brand_name": "Melphalan Hydrochloride", "product_id": "83634-202_47da36c6-67e2-44c7-93d8-4f236abb73e7", "dosage_form": "KIT", "product_ndc": "83634-202", "generic_name": "melphalan hydrochloride", "labeler_name": "Avenacy Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Melphalan Hydrochloride", "application_number": "ANDA211463", "marketing_category": "ANDA", "marketing_start_date": "20231218", "listing_expiration_date": "20261231"}