melphalan hydrochloride

Generic: melphalan hydrochloride

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

Drug Facts

Product Profile

Brand Name melphalan hydrochloride
Generic Name melphalan hydrochloride
Labeler meitheal pharmaceuticals inc.
Dosage Form KIT
Routes
INTRAVENOUS
Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-132
Product ID 71288-132_a02b7696-e6b3-46c9-9a66-142465157e70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212960
Listing Expiration 2026-12-31
Marketing Start 2021-05-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288132
Hyphenated Format 71288-132

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 ANDA212960 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg
  • 10 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (71288-132-90) * 15 mL in 1 VIAL, SINGLE-DOSE (71288-130-15) * 10 mL in 1 VIAL, SINGLE-USE (71288-131-10)
source: ndc

Packages (1)

71288-132-90 1 KIT in 1 CARTON (71288-132-90) * 15 mL in 1 VIAL, SINGLE-DOSE (71288-130-15) * 10 mL in 1 VIAL, SINGLE-USE (71288-131-10)

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": "a02b7696-e6b3-46c9-9a66-142465157e70", "openfda": {"rxcui": ["311487"], "spl_set_id": ["d99b3865-e0f0-482a-9ec6-da642e5104ea"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (71288-132-90)  *  15 mL in 1 VIAL, SINGLE-DOSE (71288-130-15)  *  10 mL in 1 VIAL, SINGLE-USE (71288-131-10)", "package_ndc": "71288-132-90", "marketing_start_date": "20210528"}], "brand_name": "Melphalan hydrochloride", "product_id": "71288-132_a02b7696-e6b3-46c9-9a66-142465157e70", "dosage_form": "KIT", "product_ndc": "71288-132", "generic_name": "Melphalan hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Melphalan hydrochloride", "application_number": "ANDA212960", "marketing_category": "ANDA", "marketing_start_date": "20210528", "listing_expiration_date": "20261231"}