Home NDC 50474-500 Nayzilam
Product NDC 50474-500
11-digit product format 504740500
Labeler code 50474
Product ID 50474-500_5776d86f-c632-429f-ac0b-88ade1a3930c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name midazolam
Dosage form SPRAY
Route NASAL
Labeler UCB, Inc.
Application NDA211321
Marketing category NDA
Marketing start 2019-05-17
Substance MIDAZOLAM
Active strength 5 mg/.1mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
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 42 .
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 N211321-001 NAYZILAM MIDAZOLAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211321-001 ODE-243 2026-05-17
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 · 42 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 2026-08-18 06:07:40 2026-07 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 d8e5a09893c0…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 60 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nayzilam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIDAZOLAM 5 mg/.1mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R60L0SM5BC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2173494 Internal RxNorm lookup 2173500 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 50474-500-14 Nayzilam 0.1 mL in 1 VIAL, SINGLE-DOSE SPRAY 0.1 4 50474-500-14 Nayzilam 1 in 1 BLISTER PACK SPRAY 1 4 50474-500-15 Nayzilam 2 in 1 CARTON SPRAY 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50474-500 NAYZILAM (MIDAZOLAM) SPRAY [UCB, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20230131_2b29422e-54d5-4a49-8522-e9cf752368c3.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 50474-500-14 50474050014 0.1 mL in 1 VIAL, SINGLE-DOSE 0.1 ml Historical 50474-500-15 50474050015 2 BLISTER PACK in 1 CARTON (50474-500-15) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (50474-500-14) / .1 mL in 1 VIAL, SINGLE-DOSE 2 blister pack 2019-05-17 0000-00-00 No No Current