melphalan hydrochloride

Generic: melphalan hydrochloride

Labeler: bpi labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name melphalan hydrochloride
Generic Name melphalan hydrochloride
Labeler bpi labs llc
Dosage Form KIT
Manufacturer
BPI Labs LLC

Identifiers & Regulatory

Product NDC 54288-109
Product ID 54288-109_731e5310-a610-419d-bae0-89d4d2702731
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209197
Listing Expiration 2026-12-31
Marketing Start 2021-07-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54288109
Hyphenated Format 54288-109

Supplemental Identifiers

RxCUI
311487
UPC
0354288109024

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 ANDA209197 (source: ndc)

Resolved Composition

Strengths
  • 50 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (54288-109-02) * 10 mL in 1 VIAL, SINGLE-DOSE (54288-106-01) * 10 mL in 1 VIAL, SINGLE-USE (54288-107-01)
source: ndc

Packages (1)

54288-109-02 1 KIT in 1 CARTON (54288-109-02) * 10 mL in 1 VIAL, SINGLE-DOSE (54288-106-01) * 10 mL in 1 VIAL, SINGLE-USE (54288-107-01)

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": "731e5310-a610-419d-bae0-89d4d2702731", "openfda": {"upc": ["0354288109024"], "rxcui": ["311487"], "spl_set_id": ["dab93975-0587-4f12-848c-9130bb02d036"], "manufacturer_name": ["BPI Labs LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (54288-109-02)  *  10 mL in 1 VIAL, SINGLE-DOSE (54288-106-01)  *  10 mL in 1 VIAL, SINGLE-USE (54288-107-01)", "package_ndc": "54288-109-02", "marketing_start_date": "20210702"}], "brand_name": "Melphalan hydrochloride", "product_id": "54288-109_731e5310-a610-419d-bae0-89d4d2702731", "dosage_form": "KIT", "product_ndc": "54288-109", "generic_name": "Melphalan Hydrochloride", "labeler_name": "BPI Labs LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Melphalan hydrochloride", "application_number": "ANDA209197", "marketing_category": "ANDA", "marketing_start_date": "20210702", "listing_expiration_date": "20261231"}