sprycel

Generic: dasatinib

Labeler: e.r. squibb & sons, l.l.c.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sprycel
Generic Name dasatinib
Labeler e.r. squibb & sons, l.l.c.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dasatinib 80 mg/1

Manufacturer
E.R. Squibb & Sons, L.L.C.

Identifiers & Regulatory

Product NDC 0003-0855
Product ID 0003-0855_8f0a3afc-dde4-40d1-941d-68efd3f62adc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021986
Listing Expiration 2026-12-31
Marketing Start 2010-10-28

Pharmacologic Class

Classes
cytochrome p450 3a4 inhibitors [moa] kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00030855
Hyphenated Format 0003-0855

Supplemental Identifiers

RxCUI
643105 643107 643109 643173 643175 643177 799047 799830 1045402 1045404 1045406 1045408
UNII
RBZ1571X5H

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 sprycel (source: ndc)
Generic Name dasatinib (source: ndc)
Application Number NDA021986 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0003-0855-22) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (1)

0003-0855-22 1 BOTTLE in 1 CARTON (0003-0855-22) / 30 TABLET in 1 BOTTLE

Ingredients (1)

dasatinib (80 mg/1)

Linked Drug Pages (1)

SPRYCEL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8f0a3afc-dde4-40d1-941d-68efd3f62adc", "openfda": {"unii": ["RBZ1571X5H"], "rxcui": ["643105", "643107", "643109", "643173", "643175", "643177", "799047", "799830", "1045402", "1045404", "1045406", "1045408"], "spl_set_id": ["4764f37b-c9e6-4ede-bcc2-8a03b7c521df"], "manufacturer_name": ["E.R. Squibb & Sons, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0003-0855-22)  / 30 TABLET in 1 BOTTLE", "package_ndc": "0003-0855-22", "marketing_start_date": "20101028"}], "brand_name": "SPRYCEL", "product_id": "0003-0855_8f0a3afc-dde4-40d1-941d-68efd3f62adc", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0003-0855", "generic_name": "dasatinib", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SPRYCEL", "active_ingredients": [{"name": "DASATINIB", "strength": "80 mg/1"}], "application_number": "NDA021986", "marketing_category": "NDA", "marketing_start_date": "20101028", "listing_expiration_date": "20261231"}