melphalan

Generic: melphalan hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name melphalan
Generic Name melphalan hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form KIT
Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-760
Product ID 63323-760_f3373f9b-1680-411c-922f-df58a559a6aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203393
Listing Expiration 2027-12-31
Marketing Start 2017-12-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323760
Hyphenated Format 63323-760

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 (source: ndc)
Generic Name melphalan hydrochloride (source: ndc)
Application Number ANDA203393 (source: ndc)

Resolved Composition

Strengths
  • 50 mg
  • 10 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (63323-760-20) * 10 mL in 1 VIAL, SINGLE-DOSE (63323-761-20) * 10 mL in 1 VIAL, SINGLE-USE (63323-732-10)
source: ndc

Packages (1)

63323-760-20 1 KIT in 1 CARTON (63323-760-20) * 10 mL in 1 VIAL, SINGLE-DOSE (63323-761-20) * 10 mL in 1 VIAL, SINGLE-USE (63323-732-10)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Melphalan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "f3373f9b-1680-411c-922f-df58a559a6aa", "openfda": {"rxcui": ["311487"], "spl_set_id": ["e9c2efee-173d-4795-96d8-7aae5b3a3073"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (63323-760-20)  *  10 mL in 1 VIAL, SINGLE-DOSE (63323-761-20)  *  10 mL in 1 VIAL, SINGLE-USE (63323-732-10)", "package_ndc": "63323-760-20", "marketing_start_date": "20171222"}], "brand_name": "Melphalan", "product_id": "63323-760_f3373f9b-1680-411c-922f-df58a559a6aa", "dosage_form": "KIT", "product_ndc": "63323-760", "generic_name": "Melphalan Hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Melphalan", "application_number": "ANDA203393", "marketing_category": "ANDA", "marketing_start_date": "20171222", "listing_expiration_date": "20271231"}