Nymalize

Product NDC: 24338-205
11-digit product format: 243380205
Labeler code: 24338
Product ID: 24338-205_4abde477-2f66-41a2-86df-091843c5e7ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nimodipine
Dosage form: SOLUTION
Route: ORAL
Labeler: Arbor Pharmaceuticals
Application: NDA203340
Marketing category: NDA
Marketing start: 2017-04-06
Marketing end: 0000-00-00
Substance: NIMODIPINE
Active strength: 30 mg/10mL
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	24338-205		D	Discontinued by firm		2026-08-03
excluded package	package	24338-205	24338-205-12	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	24338-205-12	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	24338-205-12	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	24338-205-12	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	24338-205-12	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	24338-205-12	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	24338-205-12	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	24338-205-12	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	24338-205-12	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	24338-205-12	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	24338-205-12	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	24338-205-12	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	24338-205-12	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	24338-205-12	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	24338-205-12	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	24338-205-12	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
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 · 78 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	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…`
2021-12-28 21:50 UTC	2021-12	N203340-002	NYMALIZE	6MG/ML	SOLUTION / ORAL		RLD, RS	2020-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203340-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203340-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203340-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203340-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203340-002	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203340-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 216 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	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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203340-002	11413277	2038-04-16	U-2804	Drug product	2022-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203340-002	11806338	2038-04-16		Drug product	2023-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203340-002	8517997	2024-05-14		Drug product	2020-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203340-002	10342787	2038-04-16	U-2804	Drug product	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203340-002	10576070	2038-04-16	U-2804	Drug product	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203340-002	11207306	2038-04-16	U-2804		2022-01-26	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N203340-001	ODE-46	2020-05-10	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N203340-001	ODE-46	2020-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203340-001	ODE-46	2020-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203340-001	ODE-46	2020-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203340-001	ODE-46	2020-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203340-001	ODE-46	2020-05-10	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24338-205-12	2023-04-20	C162847	48780-1	d6a99b39-6ca4-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use NYMALIZE ® safely and effectively. See full prescribing information for NYMALIZE. NYMALIZE (nimodipine) oral solution Initial U.S. Approval: 1988
24338-205-12	2022-01-28	C162847	48780-1	d6a99b39-6ca4-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use NYMALIZE ® safely and effectively. See full prescribing information for NYMALIZE. NYMALIZE (nimodipine) oral solution Initial U.S. Approval: 1988

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24338-205-10	ML - Milliliter	24338-205	e000ac54-72f0-4260-88fd-5a9dae8ad7f1	1	2017-10-13
24338-205-12	ML - Milliliter	24338-205	2a092cd2-4504-405d-bfd9-00702512501f	1	2017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
nimodipine	ACTIVE INGREDIENT	57WA9QZ5WH	NYMALIZE (NIMODIPINE) SOLUTION [ARBOR PHARMACEUTICALS]	3
nimodipine	ACTIVE MOIETY	57WA9QZ5WH	NYMALIZE (NIMODIPINE) SOLUTION [ARBOR PHARMACEUTICALS]	3
alcohol	INACTIVE INGREDIENT	3K9958V90M	NYMALIZE (NIMODIPINE) SOLUTION [ARBOR PHARMACEUTICALS]	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	NYMALIZE (NIMODIPINE) SOLUTION [ARBOR PHARMACEUTICALS]	3
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NYMALIZE (NIMODIPINE) SOLUTION [ARBOR PHARMACEUTICALS]	3
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	NYMALIZE (NIMODIPINE) SOLUTION [ARBOR PHARMACEUTICALS]	3
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	NYMALIZE (NIMODIPINE) SOLUTION [ARBOR PHARMACEUTICALS]	3
sodium phosphate, monobasic	INACTIVE INGREDIENT	3980JIH2SW	NYMALIZE (NIMODIPINE) SOLUTION [ARBOR PHARMACEUTICALS]	3
water	INACTIVE INGREDIENT	059QF0KO0R	NYMALIZE (NIMODIPINE) SOLUTION [ARBOR PHARMACEUTICALS]	3

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
Nymalize	NIMODIPINE	Azurity Pharmaceuticals, Inc.	e660fa26-b5c4-4d6d-8887-9e22b6666a10	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203340 application number: NDA203340

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57WA9QZ5WH	NIMODIPINE	66085-59-4	NIMODIPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24338-205-12	24338020512	12 PACKAGE in 1 CARTON (24338-205-12) > 1 CUP, UNIT-DOSE in 1 PACKAGE (24338-205-10) > 10 mL in 1 CUP, UNIT-DOSE	12 package	2017-04-06	0000-00-00	No	No	Current