FDA.reportPublic FDA data

Nymalize

Product NDC
24338-260
11-digit product format
243380260
Labeler code
24338
Product ID
24338-260_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
60 mg/10mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Nymalize
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIMODIPINE60 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WA9QZ5WH
Rxcui2361311, 2361313

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1c652b1c-164c-48c3-ae98-4d96fe16a1a2Product name120251114
d941181f-1f0c-c11b-5ab9-a359f0ca2e83Product name220250304
4b413d86-9489-373a-0c33-320b9817a388Product name320150731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24338-260-08Nymalize237 mL in 1 BOTTLESOLUTION2379
24338-260-10Nymalize1 in 1 PACKAGESOLUTION19
24338-260-10Nymalize10 mL in 1 SYRINGE, PLASTICSOLUTION109
24338-260-12Nymalize12 in 1 CARTONSOLUTION129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-260-08ML - Milliliter24338-26018f4dfed-2a91-4d49-a563-8d9e9f166ebf12021-07-15
24338-260-10ML - Milliliter24338-2602ef2b023-08ca-4b78-890c-df6d111a1e2012020-05-08
24338-260-12ML - Milliliter24338-260590cdd47-51b4-4c8d-b3ed-31bc53772f0612020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-260NYMALIZE (NIMODIPINE) SOLUTION [AZURITY PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20240907_e660fa26-b5c4-4d6d-8887-9e22b6666a10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2361311niMODipine 6 MG/mL Oral SolutionPSNe660fa26-b5c4-4d6d-8887-9e22b6666a109
2361313Nymalize 6 MG/mL Oral SolutionPSNe660fa26-b5c4-4d6d-8887-9e22b6666a109
2361313nimodipine 6 MG/ML Oral Solution [Nymalize]SBDe660fa26-b5c4-4d6d-8887-9e22b6666a109
2361311nimodipine 6 MG/ML Oral SolutionSCDe660fa26-b5c4-4d6d-8887-9e22b6666a109
2361311nimodipine 30 MG per 5 mL Oral SolutionSYe660fa26-b5c4-4d6d-8887-9e22b6666a109
2361311nimodipine 60 MG per 10 mL Oral SolutionSYe660fa26-b5c4-4d6d-8887-9e22b6666a109
2361313Nymalize 30 MG per 5 mL Oral SolutionSYe660fa26-b5c4-4d6d-8887-9e22b6666a109
2361313Nymalize 6 MG/ML Oral SolutionSYe660fa26-b5c4-4d6d-8887-9e22b6666a109
2361313Nymalize 60 MG per 10 mL Oral SolutionSYe660fa26-b5c4-4d6d-8887-9e22b6666a109

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-260-0824338026008237 mL in 1 BOTTLE (24338-260-08) 237 ml2021-07-130000-00-00NoNoCurrent
24338-260-10243380260101 in 1 PACKAGEHistorical
24338-260-122433802601212 PACKAGE in 1 CARTON (24338-260-12) / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-260-10) / 10 mL in 1 SYRINGE, PLASTIC12 package2020-05-040000-00-00NoNoCurrent