cyclophosphamide

Generic: cyclophosphamide

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclophosphamide
Generic Name cyclophosphamide
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cyclophosphamide 50 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-619
Product ID 46708-619_9c04aa3c-6a2b-4ad4-b3df-87cc168cf93d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215892
Listing Expiration 2026-12-31
Marketing Start 2022-11-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708619
Hyphenated Format 46708-619

Supplemental Identifiers

RxCUI
1437968 1437969
UPC
0346708618315
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 ANDA215892 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (46708-619-31)
source: ndc

Packages (1)

46708-619-31 100 CAPSULE in 1 BOTTLE (46708-619-31)

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": "9c04aa3c-6a2b-4ad4-b3df-87cc168cf93d", "openfda": {"upc": ["0346708618315"], "unii": ["8N3DW7272P"], "rxcui": ["1437968", "1437969"], "spl_set_id": ["9e699cf7-860e-4c03-9760-0c24d56df2de"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (46708-619-31)", "package_ndc": "46708-619-31", "marketing_start_date": "20221123"}], "brand_name": "Cyclophosphamide", "product_id": "46708-619_9c04aa3c-6a2b-4ad4-b3df-87cc168cf93d", "dosage_form": "CAPSULE", "product_ndc": "46708-619", "generic_name": "Cyclophosphamide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclophosphamide", "active_ingredients": [{"name": "CYCLOPHOSPHAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA215892", "marketing_category": "ANDA", "marketing_start_date": "20221123", "listing_expiration_date": "20261231"}