Nymalize

Product NDC: 24338-200
Requested package NDC: 24338-200-12
11-digit product format: 243380200
Labeler code: 24338
Product ID: 24338-200_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: 2013-06-03
Marketing end: 0000-00-00
Substance: NIMODIPINE
Active strength: 60 mg/20mL
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	24338-200	24338-200-12	D	Discontinued by firm		2026-07-31

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N203340-001	NYMALIZE	NIMODIPINE	3MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2013-05-10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.

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
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N203340-002	NYMALIZE	6MG/ML	SOLUTION / ORAL	AB	RLD, RS	2020-04-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N203340-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N203340-002	10342787	2038-04-16	U-2804	Drug product	2020-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N203340-002	10576070	2038-04-16	U-2804	Drug product	2020-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N203340-002	11207306	2038-04-16	U-2804		2022-01-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N203340-002	11413277	2038-04-16	U-2804	Drug product	2022-08-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N203340-002	11806338	2038-04-16		Drug product	2023-11-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N203340-002	12186308	2038-04-16	U-2804	Drug product	2025-01-27	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24338-200-12	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
24338-200-16	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
24338-200-12	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
24338-200-16	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
24338-200-12	ML - Milliliter	24338-200	f536ad84-035b-4021-b0e9-d8b7db9ed6e9	1	2013-10-17
24338-200-16	ML - Milliliter	24338-200	37403a32-ec4d-441a-8f23-538166a2d06c	1	2013-08-02
24338-200-20	ML - Milliliter	24338-200	a33563d5-6051-4087-9cde-e7a8179db764	1	2013-10-17

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

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
24338-200-12	24338020012	12 PACKAGE in 1 CARTON (24338-200-12) > 1 CUP, UNIT-DOSE in 1 PACKAGE (24338-200-20) > 20 mL in 1 CUP, UNIT-DOSE	12 package	2013-09-09	0000-00-00	No	No	Current