Home NDC 24338-050 Gliadel
Product NDC 24338-050
11-digit product format 243380050
Labeler code 24338
Product ID 24338-050_288ecd1b-0244-dd13-e063-6394a90a739d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carmustine
Dosage form WAFER
Route INTRACAVITARY
Labeler Azurity Pharmaceuticals, Inc.
Application NDA020637
Marketing category NDA
Marketing start 2012-12-13
Substance CARMUSTINE
Active strength 7.7 mg/1
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020637-001 GLIADEL CARMUSTINE 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23
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 2 · 41 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 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020637-001 GLIADEL 7.7MG IMPLANT / INTRACRANIAL RLD, RS 1996-09-23 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Gliadel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARMUSTINE 7.7 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U68WG3173Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 212994 Internal RxNorm lookup 309013 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 24338-050-08 Gliadel 1 in 1 POUCH WAFER 1 8 24338-050-08 Gliadel 8 in 1 BOX WAFER 8 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24338-050 GLIADEL (CARMUSTINE) WAFER [AZURITY PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241208_38962a55-a514-4c48-bea5-f99a8da4beec.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24338-050-08 24338005008 8 POUCH in 1 BOX (24338-050-08) / 1 WAFER in 1 POUCH 8 pouch 2012-12-13 0000-00-00 No No Current