Prescription drug · ANDA
Sumatriptan NDC 65145-118
Sumatriptan succinate 6 mg/.5mL · Injection, Solution · Subcutaneous · Caplin Steriles Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65145-118-05 | 65145011805 | 5 VIAL in 1 CARTON (65145-118-05) / .5 mL in 1 VIAL (65145-118-01)Marketed from Sep 28, 2024 |
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)
- Sumatriptan
- Generic name (nonproprietary)
- sumatriptan
- Active ingredients
- Sumatriptan succinate — 6 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Caplin Steriles Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213998
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 65145-118_eeefceae-7dbe-4215-90b2-59b5d509547fSPL ID eeefceae-7dbe-4215-90b2-59b5d509547fSPL set ID 01293e09-d49a-411d-9647-6f23318ac201RxCUI 313165UNII J8BDZ68989UPC 0365145118011
- Pharmacologic class
- Serotonin-1b and Serotonin-1d Receptor Agonist
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N465145011805followed by a unit qualifier and the quantityPackage 65145-0118-05. 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)
Sumatriptan Injection, USP is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: • Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan Injection reconsider the diagnosis before Sumatriptan Injection is administered to treat any subsequent attacks. • Sumatriptan Injection is not indicated for the prevention of migraine attacks or cluster headache attacks. Sumatriptan injection, USP is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for: • Acute treatment of migraine…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213998
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 |
|---|---|---|---|---|
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-7957 |
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | Somerset Therapeutics, LLC | 70069-804 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 6 mg/.5mL | InjectionSubcutaneous | Xellia Pharmaceuticals USA LLC | 70594-068 |
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | Armas Pharmaceuticals Inc. | 72485-518 |