Prescription drug · NDA
Nymalize (Nimodipine) NDC 24338-260
Nimodipine 60 mg/10mL · Solution · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24338-260-08 | 2433802600824338026008 | 237 mL in 1 BOTTLE (24338-260-08)Marketed from Jul 13, 2021 | |
| 24338-260-12 | 2433802601224338026012 | 12 PACKAGE in 1 CARTON (24338-260-12) / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-260-10) / 10 mL in 1 SYRINGE, PLASTICMarketed from May 4, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nymalize
- Generic name (nonproprietary)
- nimodipine
- Active ingredients
- Nimodipine — 60 mg/10mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Azurity Pharmaceuticals, Inc.NDC labeler code 24338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203340
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 24338-260_217909ac-1821-85a8-e063-6294a90a9e0cSPL ID 217909ac-1821-85a8-e063-6294a90a9e0cSPL set ID e660fa26-b5c4-4d6d-8887-9e22b6666a10RxCUI 2361311, 2361313UNII 57WA9QZ5WH
- Pharmacologic class
- Dihydropyridine Calcium Channel Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N424338026008followed by a unit qualifier and the quantityPackage 24338-0260-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
NYMALIZE is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V). NYMALIZE is a dihydropyridine calcium channel blocker indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 24338-260
- What is NDC 24338-260?
- 24338-260 is the product NDC for Nymalize (nimodipine), Nimodipine 60 mg/10mL solution, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nymalize (Nimodipine).
- What is the active ingredient?
- Nimodipine.
- Who is the labeler?
- Azurity Pharmaceuticals, Inc., NDC labeler code 24338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nymalize?
- 1 other product NDC are listed under this name. See all Nymalize NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nymalize products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nymalizenimodipine | Nimodipine 30 mg/5mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 24338-230 | 24338-0230-1224338-0230-30 |
Other NDCs under NDA 203340
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nymalizenimodipine | Nimodipine 30 mg/5mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 24338-230 |