melphalan hydrochloride

Generic: melphalan hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name melphalan hydrochloride
Generic Name melphalan hydrochloride
Labeler mylan institutional llc
Dosage Form KIT
Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-195
Product ID 67457-195_14d237c9-0b9f-4101-ae53-c6ffe9928801
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090270
Listing Expiration 2026-12-31
Marketing Start 2013-01-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457195
Hyphenated Format 67457-195

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 ANDA090270 (source: ndc)

Resolved Composition

Strengths
  • 50 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (67457-195-01) * 10 mL in 1 VIAL, GLASS (67457-193-50) * 10 mL in 1 VIAL, GLASS (67457-194-10)
source: ndc

Packages (1)

67457-195-01 1 KIT in 1 CARTON (67457-195-01) * 10 mL in 1 VIAL, GLASS (67457-193-50) * 10 mL in 1 VIAL, GLASS (67457-194-10)

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 
{"spl_id": "14d237c9-0b9f-4101-ae53-c6ffe9928801", "openfda": {"rxcui": ["311487"], "spl_set_id": ["a8bf1877-fd06-4ef6-b82d-fe0ff1956bde"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (67457-195-01)  *  10 mL in 1 VIAL, GLASS (67457-193-50)  *  10 mL in 1 VIAL, GLASS (67457-194-10)", "package_ndc": "67457-195-01", "marketing_start_date": "20130110"}], "brand_name": "Melphalan Hydrochloride", "product_id": "67457-195_14d237c9-0b9f-4101-ae53-c6ffe9928801", "dosage_form": "KIT", "product_ndc": "67457-195", "generic_name": "Melphalan Hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Melphalan Hydrochloride", "application_number": "ANDA090270", "marketing_category": "ANDA", "marketing_start_date": "20130110", "listing_expiration_date": "20261231"}