Prescription drug · ANDA
Sumatriptan Succinate NDC 43598-768
Sumatriptan succinate 6 mg/.5mL · Injection · Subcutaneous · Dr. Reddys Laboratories Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-768-23 | 43598076823 | 2 SYRINGE in 1 CARTON (43598-768-23) / .5 mL in 1 SYRINGE (43598-768-11)Marketed from Apr 20, 2023 |
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 Succinate
- Generic name (nonproprietary)
- sumatriptan succinate
- Active ingredients
- Sumatriptan succinate — 6 mg/.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090495
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43598-768_d0cf8002-71d2-7e4b-f04e-0120cc95dc1aSPL ID d0cf8002-71d2-7e4b-f04e-0120cc95dc1aSPL set ID 8fef1176-7a38-eca3-22ca-83efe5ca6620RxCUI 1657151UNII J8BDZ68989UPC 0343598768113
- 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
N443598076823followed by a unit qualifier and the quantityPackage 43598-0768-23. 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 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 or cluster headache 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 or cluster headache attacks. Sumatriptan injection is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for: Acute treatment of migraine w…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090495
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 Succinate | Sumatriptan succinate 6 mg/.5mL | InjectionSubcutaneous | Dr. Reddy's Laboratories Limited | 55111-693 |
| Sumatriptan Succinate | Sumatriptan succinate 6 mg/.5mL | InjectionSubcutaneous | Sportpharm LLC | 85766-238 |
| Sumatriptan Succinate | Sumatriptan succinate 6 mg/.5mL | InjectionSubcutaneous | NorthStar Rx LLC | 72603-141 |