Home NDC 24338-230 Nymalize
Product NDC 24338-230
11-digit product format 243380230
Labeler code 24338
Product ID 24338-230_217909ac-1821-85a8-e063-6294a90a9e0c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nimodipine
Dosage form SOLUTION
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA203340
Marketing category NDA
Marketing start 2020-05-04
Substance NIMODIPINE
Active strength 30 mg/5mL
Pharmacologic classes Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203340-001 NYMALIZE NIMODIPINE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 N203340-002 NYMALIZE NIMODIPINE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N203340-002 AB
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27
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 · 80 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 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL AB RLD, RS 2020-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203340-001 NYMALIZE 3MG/ML SOLUTION / ORAL RLD 2013-05-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203340-001 NYMALIZE 3MG/ML SOLUTION / ORAL RLD 2013-05-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203340-001 NYMALIZE 60MG/20ML SOLUTION / ORAL RLD, RS 2013-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2013-05-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203340-002 NYMALIZE 6MG/ML SOLUTION / ORAL RLD, RS 2020-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203340-001 NYMALIZE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION / ORAL RLD 2013-05-10 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 222 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 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 11413277 2038-04-16 U-2804 Drug product 2022-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 11806338 2038-04-16 Drug product 2023-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203340-002 12186308 2038-04-16 U-2804 Drug product 2025-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 8517997 2024-05-14 Drug product 2020-07-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 10342787 2038-04-16 U-2804 Drug product 2020-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 10576070 2038-04-16 U-2804 Drug product 2020-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203340-002 11207306 2038-04-16 U-2804 2022-01-26 03ed91905a0d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Nymalize
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NIMODIPINE 30 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57WA9QZ5WH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2361311 Internal RxNorm lookup 2361313 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 24338-230-05 Nymalize 5 mL in 1 SYRINGE, PLASTIC SOLUTION 5 9 24338-230-05 Nymalize 1 in 1 PACKAGE SOLUTION 1 9 24338-230-12 Nymalize 12 in 1 CARTON SOLUTION 12 9 24338-230-15 Nymalize 5 mL in 1 SYRINGE, PLASTIC SOLUTION 5 9 24338-230-15 Nymalize 1 in 1 BLISTER PACK SOLUTION 1 9 24338-230-30 Nymalize 12 in 1 CARTON SOLUTION 12 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24338-230 NYMALIZE (NIMODIPINE) SOLUTION [AZURITY PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 6 package rows 20240907_e660fa26-b5c4-4d6d-8887-9e22b6666a10.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 24338-230-05 24338023005 5 mL in 1 SYRINGE, PLASTIC 5 ml Historical 24338-230-12 24338023012 12 PACKAGE in 1 CARTON (24338-230-12) / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-230-05) / 5 mL in 1 SYRINGE, PLASTIC 12 package 2020-05-04 0000-00-00 No No Current 24338-230-15 24338023015 5 mL in 1 SYRINGE, PLASTIC 5 ml Historical 24338-230-30 24338023030 12 BLISTER PACK in 1 CARTON (24338-230-30) / 1 SYRINGE, PLASTIC in 1 BLISTER PACK (24338-230-15) / 5 mL in 1 SYRINGE, PLASTIC 12 blister pack 2024-09-30 No No Current