cyclophosphamide

Generic: cyclophosphamide

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclophosphamide
Generic Name cyclophosphamide
Labeler hikma pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cyclophosphamide 50 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0383
Product ID 0054-0383_35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203856
Listing Expiration 2026-12-31
Marketing Start 2013-09-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540383
Hyphenated Format 0054-0383

Supplemental Identifiers

RxCUI
1437968 1437969
UNII
8N3DW7272P

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 cyclophosphamide (source: ndc)
Generic Name cyclophosphamide (source: ndc)
Application Number NDA203856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0054-0383-25)
source: ndc

Packages (1)

0054-0383-25 100 CAPSULE in 1 BOTTLE (0054-0383-25)

Ingredients (1)

cyclophosphamide (50 mg/1)

Linked Drug Pages (1)

Cyclophosphamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4", "openfda": {"unii": ["8N3DW7272P"], "rxcui": ["1437968", "1437969"], "spl_set_id": ["8135b917-882f-4b4c-99b7-fa8ea54af4bf"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0054-0383-25)", "package_ndc": "0054-0383-25", "marketing_start_date": "20130916"}], "brand_name": "Cyclophosphamide", "product_id": "0054-0383_35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4", "dosage_form": "CAPSULE", "product_ndc": "0054-0383", "generic_name": "Cyclophosphamide", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclophosphamide", "active_ingredients": [{"name": "CYCLOPHOSPHAMIDE", "strength": "50 mg/1"}], "application_number": "NDA203856", "marketing_category": "NDA", "marketing_start_date": "20130916", "listing_expiration_date": "20261231"}