melphalan hydrochloride

Generic: melphalan hydrochloride

Labeler: arthur group llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name melphalan hydrochloride
Generic Name melphalan hydrochloride
Labeler arthur group llc
Dosage Form KIT
Routes
INTRAVENOUS
Manufacturer
Arthur Group LLC

Identifiers & Regulatory

Product NDC 84679-001
Product ID 84679-001_47e47c3a-eecb-263c-e063-6394a90a8864
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211463
Listing Expiration 2027-12-31
Marketing Start 2024-11-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84679001
Hyphenated Format 84679-001

Supplemental Identifiers

RxCUI
311487
UPC
0384679001019

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 (84679-001-01) * 15 mL in 1 VIAL, SINGLE-DOSE (84679-002-01) * 10 mL in 1 VIAL, SINGLE-USE (84679-003-01)
source: ndc

Packages (1)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "47e47c3a-eecb-263c-e063-6394a90a8864", "openfda": {"upc": ["0384679001019"], "rxcui": ["311487"], "spl_set_id": ["2254450e-4803-b947-e063-6394a90a4624"], "manufacturer_name": ["Arthur Group LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (84679-001-01)  *  15 mL in 1 VIAL, SINGLE-DOSE (84679-002-01)  *  10 mL in 1 VIAL, SINGLE-USE (84679-003-01)", "package_ndc": "84679-001-01", "marketing_start_date": "20241130"}], "brand_name": "Melphalan Hydrochloride", "product_id": "84679-001_47e47c3a-eecb-263c-e063-6394a90a8864", "dosage_form": "KIT", "product_ndc": "84679-001", "generic_name": "melphalan hydrochloride", "labeler_name": "Arthur Group LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Melphalan Hydrochloride", "application_number": "ANDA211463", "marketing_category": "ANDA", "marketing_start_date": "20241130", "listing_expiration_date": "20271231"}