Home NDC 0069-0298 Daurismo
Product NDC 0069-0298
11-digit product format 000690298
Labeler code 0069
Product ID 0069-0298_e850e390-b32e-4382-a2c7-d480c41bd3a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glasdegib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA210656
Marketing category NDA
Marketing start 2018-12-10
Substance GLASDEGIB
Active strength 25 mg/1
Pharmacologic classes Hedgehog Pathway Inhibitor [EPC], Smoothened Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210656-001 DAURISMO GLASDEGIB MALEATE EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 N210656-002 DAURISMO GLASDEGIB MALEATE EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210656-001 8431597 2028-06-29 Drug product 2018-12-18 N210656-001 8148401 2032-11-21 Drug substance, Drug product 2018-12-18 N210656-001 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 N210656-001 11168066 2036-04-13 U-3254 2021-12-08 N210656-001 11891372 2036-04-13 U-3254 2024-03-06 N210656-002 8431597 2028-06-29 Drug product 2018-12-18 N210656-002 8148401 2032-11-21 Drug substance, Drug product 2018-12-18 N210656-002 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 N210656-002 11168066 2036-04-13 U-3254 2021-12-08 N210656-002 11891372 2036-04-13 U-3254 2024-03-06
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 9 · 336 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210656-001 8431597 2028-06-29 Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-001 8148401 2029-04-14 Drug substance, Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-001 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-001 11168066 2036-04-13 U-3254 2021-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-001 11891372 2036-04-13 U-3254 2024-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 8431597 2028-06-29 Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 8148401 2029-04-14 Drug substance, Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 11168066 2036-04-13 U-3254 2021-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 11891372 2036-04-13 U-3254 2024-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 8431597 2028-06-29 Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 11168066 2036-04-13 U-3254 2021-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 11891372 2036-04-13 U-3254 2024-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 8431597 2028-06-29 Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 11168066 2036-04-13 U-3254 2021-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 11891372 2036-04-13 U-3254 2024-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210656-001 8431597 2028-06-29 Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-001 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-001 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-001 11168066 2036-04-13 U-3254 2021-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-001 11891372 2036-04-13 U-3254 2024-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 8431597 2028-06-29 Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 11168066 2036-04-13 U-3254 2021-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 11891372 2036-04-13 U-3254 2024-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 8431597 2028-06-29 Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 11168066 2036-04-13 U-3254 2021-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 11891372 2036-04-13 U-3254 2024-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 8431597 2028-06-29 Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 11168066 2036-04-13 U-3254 2021-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 11891372 2036-04-13 U-3254 2024-03-06 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Daurismo
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLASDEGIB 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K673DMO5H9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2105850 Internal RxNorm lookup 2105856 Internal RxNorm lookup 2105858 Internal RxNorm lookup 2105860 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-0298-60 Daurismo 60 in 1 BOTTLE TABLET, FILM COATED 60 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0298 DAURISMO (GLASDEGIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 9 Current NDC, Legacy NDC, 1 package rows 20250121_204a6f7e-c9a4-472b-abd2-9527bda64d17.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daurismo GLASDEGIB Pfizer Laboratories Div Pfizer Inc 204a6f7e-c9a4-472b-abd2-9527bda64d17 2025-12-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 210656 application number: NDA210656 ndc (product): 0069-0298
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0069-0298-60 00069029860 60 TABLET, FILM COATED in 1 BOTTLE (0069-0298-60) 2018-12-10 0000-00-00 No No Current