decitabine

Generic: decitabine

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name decitabine
Generic Name decitabine
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

decitabine 50 mg/10mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-528
Product ID 68083-528_39a26b24-e9d4-4974-9788-d025c51fc94f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205539
Listing Expiration 2026-12-31
Marketing Start 2020-11-23

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 68083528
Hyphenated Format 68083-528

Supplemental Identifiers

RxCUI
636631
UPC
0368083528010
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 ANDA205539 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-528-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01) / 10 mL in 1 VIAL, SINGLE-DOSE

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": "39a26b24-e9d4-4974-9788-d025c51fc94f", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0368083528010"], "unii": ["776B62CQ27"], "rxcui": ["636631"], "spl_set_id": ["39a26b24-e9d4-4974-9788-d025c51fc94f"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-528-01", "marketing_start_date": "20201123"}], "brand_name": "decitabine", "product_id": "68083-528_39a26b24-e9d4-4974-9788-d025c51fc94f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68083-528", "generic_name": "decitabine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "decitabine", "active_ingredients": [{"name": "DECITABINE", "strength": "50 mg/10mL"}], "application_number": "ANDA205539", "marketing_category": "ANDA", "marketing_start_date": "20201123", "listing_expiration_date": "20261231"}