decitabine

Generic: decitabine

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name decitabine
Generic Name decitabine
Labeler dr. reddy's laboratories inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

decitabine 50 mg/10mL

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-427
Product ID 43598-427_4ba66c50-ec05-feac-7d83-99e436fc53ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203131
Listing Expiration 2026-12-31
Marketing Start 2014-12-05

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598427
Hyphenated Format 43598-427

Supplemental Identifiers

RxCUI
636631
UNII
776B62CQ27
NUI
N0000000233 N0000175595

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 decitabine (source: ndc)
Generic Name decitabine (source: ndc)
Application Number ANDA203131 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (43598-427-37) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

43598-427-37 1 VIAL, SINGLE-USE in 1 CARTON (43598-427-37) / 10 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

decitabine (50 mg/10mL)

Linked Drug Pages (1)

Decitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4ba66c50-ec05-feac-7d83-99e436fc53ee", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["776B62CQ27"], "rxcui": ["636631"], "spl_set_id": ["358764ca-4c69-d516-af0c-bf8a348d26ca"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (43598-427-37)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "43598-427-37", "marketing_start_date": "20141205"}], "brand_name": "Decitabine", "product_id": "43598-427_4ba66c50-ec05-feac-7d83-99e436fc53ee", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "43598-427", "generic_name": "Decitabine", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Decitabine", "active_ingredients": [{"name": "DECITABINE", "strength": "50 mg/10mL"}], "application_number": "ANDA203131", "marketing_category": "ANDA", "marketing_start_date": "20141205", "listing_expiration_date": "20261231"}