Home NDC 50474-500 Nayzilam
Product NDC 50474-500
11-digit product format 504740500
Labeler code 50474
Product ID 50474-500_5df98158-3d4e-e281-e063-6294a90ac623
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211321-001 NAYZILAM 5MG/SPRAY SPRAY / NASAL RLD, RS 2019-05-17 84e616aacf4f…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…
Observed Orange Book patent history# Patent history page 1 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211321-001 8217033 2028-01-18 U-2526 Drug product 2019-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211321-001 8809322 2028-01-18 Drug product 2019-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211321-001 9289432 2028-01-18 U-2526 Drug product 2019-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211321-001 9687495 2028-01-18 U-2526 Drug product 2019-05-31 84e616aacf4f…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 62 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nayzilam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIDAZOLAM 5 mg/.1mL
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
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