nymalize

Generic: nimodipine

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nymalize
Generic Name nimodipine
Labeler azurity pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

nimodipine 30 mg/5mL

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 24338-230
Product ID 24338-230_217909ac-1821-85a8-e063-6294a90a9e0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203340
Listing Expiration 2026-12-31
Marketing Start 2020-05-04

Pharmacologic Class

Established (EPC)
dihydropyridine calcium channel blocker [epc]
Mechanism of Action
calcium channel antagonists [moa]
Chemical Structure
dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24338230
Hyphenated Format 24338-230

Supplemental Identifiers

RxCUI
2361311 2361313
UNII
57WA9QZ5WH
NUI
N0000000069 N0000175421 M0006414

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nymalize (source: ndc)
Generic Name nimodipine (source: ndc)
Application Number NDA203340 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
source: ndc
Packaging
  • 12 PACKAGE in 1 CARTON (24338-230-12) / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-230-05) / 5 mL in 1 SYRINGE, PLASTIC
  • 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
source: ndc

Packages (2)

24338-230-12 12 PACKAGE in 1 CARTON (24338-230-12) / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-230-05) / 5 mL in 1 SYRINGE, PLASTIC 24338-230-30 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

Ingredients (1)

nimodipine (30 mg/5mL)

Linked Drug Pages (1)

Nymalize ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "217909ac-1821-85a8-e063-6294a90a9e0c", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["57WA9QZ5WH"], "rxcui": ["2361311", "2361313"], "spl_set_id": ["e660fa26-b5c4-4d6d-8887-9e22b6666a10"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 PACKAGE in 1 CARTON (24338-230-12)  / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-230-05)  / 5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "24338-230-12", "marketing_start_date": "20200504"}, {"sample": false, "description": "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", "package_ndc": "24338-230-30", "marketing_start_date": "20240930"}], "brand_name": "Nymalize", "product_id": "24338-230_217909ac-1821-85a8-e063-6294a90a9e0c", "dosage_form": "SOLUTION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "24338-230", "generic_name": "nimodipine", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nymalize", "active_ingredients": [{"name": "NIMODIPINE", "strength": "30 mg/5mL"}], "application_number": "NDA203340", "marketing_category": "NDA", "marketing_start_date": "20200504", "listing_expiration_date": "20261231"}