melphalan hydrochloride

Generic: melphalan hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name melphalan hydrochloride
Generic Name melphalan hydrochloride
Labeler actavis pharma, inc.
Dosage Form KIT
Routes
INTRAVENOUS
Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 45963-686
Product ID 45963-686_0cd01d2b-3820-401c-a472-4ca4f57c7037
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206018
Marketing Start 2017-01-13
Marketing End 2026-04-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45963686
Hyphenated Format 45963-686

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 ANDA206018 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg
source: label
Packaging
  • 1 KIT in 1 PACKAGE, COMBINATION (45963-686-02) * 10 mL in 1 VIAL, SINGLE-DOSE (45963-687-49) * 10 mL in 1 VIAL, SINGLE-USE (45963-688-57)
source: ndc

Packages (1)

45963-686-02 1 KIT in 1 PACKAGE, COMBINATION (45963-686-02) * 10 mL in 1 VIAL, SINGLE-DOSE (45963-687-49) * 10 mL in 1 VIAL, SINGLE-USE (45963-688-57)

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": "0cd01d2b-3820-401c-a472-4ca4f57c7037", "openfda": {"rxcui": ["311487"], "spl_set_id": ["6c957ec5-2ab4-49c0-9f36-1df4f93e3d58"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 PACKAGE, COMBINATION (45963-686-02)  *  10 mL in 1 VIAL, SINGLE-DOSE (45963-687-49)  *  10 mL in 1 VIAL, SINGLE-USE (45963-688-57)", "package_ndc": "45963-686-02", "marketing_end_date": "20260430", "marketing_start_date": "20170113"}], "brand_name": "Melphalan Hydrochloride", "product_id": "45963-686_0cd01d2b-3820-401c-a472-4ca4f57c7037", "dosage_form": "KIT", "product_ndc": "45963-686", "generic_name": "Melphalan Hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Melphalan Hydrochloride", "application_number": "ANDA206018", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20170113"}