decitabine

Generic: decitabine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name decitabine
Generic Name decitabine
Labeler sun pharmaceutical industries, inc.
Dosage Form KIT
Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-361
Product ID 47335-361_ddc155a1-509c-4d7e-bab1-fa5891ef354e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205582
Listing Expiration 2026-12-31
Marketing Start 2014-01-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335361
Hyphenated Format 47335-361

Supplemental Identifiers

RxCUI
636631

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 NDA205582 (source: ndc)

Resolved Composition

Strengths
  • 50 mg
  • 20 ml
  • 10 ml
  • 68 mg
  • 11.6 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (47335-361-41) * 10 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL (47335-362-40)
source: ndc

Packages (1)

47335-361-41 1 KIT in 1 CARTON (47335-361-41) * 10 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL (47335-362-40)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

decitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "ddc155a1-509c-4d7e-bab1-fa5891ef354e", "openfda": {"rxcui": ["636631"], "spl_set_id": ["c155d6ba-9a16-406c-919e-65a149689ab9"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (47335-361-41)  *  10 mL in 1 VIAL, SINGLE-DOSE *  10 mL in 1 VIAL (47335-362-40)", "package_ndc": "47335-361-41", "marketing_start_date": "20140124"}], "brand_name": "decitabine", "product_id": "47335-361_ddc155a1-509c-4d7e-bab1-fa5891ef354e", "dosage_form": "KIT", "product_ndc": "47335-361", "generic_name": "decitabine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "decitabine", "application_number": "NDA205582", "marketing_category": "NDA", "marketing_start_date": "20140124", "listing_expiration_date": "20261231"}