Prescription drug · ANDA
Sumatriptan (Sumatriptan succinate) NDC 70594-068
Sumatriptan succinate 6 mg/.5mL · Injection · Subcutaneous · Xellia Pharmaceuticals USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70594-068-02 | 7059400680270594006802 | 5 VIAL in 1 CARTON (70594-068-02) / .5 mL in 1 VIAL (70594-068-01)Marketed from Jan 1, 2022 |
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 succinate
- Active ingredients
- Sumatriptan succinate — 6 mg/.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Xellia Pharmaceuticals USA LLCNDC labeler code 70594
- 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 70594-068_44ed271d-bc7e-48f7-bb63-0ecdb70fdad4SPL ID 44ed271d-bc7e-48f7-bb63-0ecdb70fdad4SPL set ID f42c6e00-e693-48f3-8e84-c3f139e1adf5RxCUI 313165UNII J8BDZ68989
- 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
N470594006802followed by a unit qualifier and the quantityPackage 70594-0068-02. 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. Sumatriptan injection, USP is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for: Acute treatment of migraine with or without aura in adults ( 1 ) Acute treatment of cluster headache in adults ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established ( 1 ) Not indicated for the prophylactic therapy of migraine or cluster headache attacks ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no r…
Excerpt only. Read the full label for complete information.
About NDC 70594-068
- What is NDC 70594-068?
- 70594-068 is the product NDC for Sumatriptan (sumatriptan succinate), Sumatriptan succinate 6 mg/.5mL injection, listed with the FDA by Xellia Pharmaceuticals USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sumatriptan (Sumatriptan succinate).
- What is the active ingredient?
- Sumatriptan succinate.
- Who is the labeler?
- Xellia Pharmaceuticals USA LLC, NDC labeler code 70594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sumatriptan?
- 75 other product NDCs are listed under this name. See all Sumatriptan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sumatriptan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | Armas Pharmaceuticals Inc. | 72485-518 | 72485-0518-05 |
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | Strides Pharma Science Limited | 64380-740 | 64380-0740-0164380-0740-02 |
| sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-151 | 83270-0151-07 |
| sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-152 | 83270-0152-07 |
| sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-005 | 83270-0005-01 |
| sumatriptan | Sumatriptan succinate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8109 | 50090-8109-00 |
| sumatriptan | Sumatriptan succinate 25 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-660 | 64980-0660-2764980-0660-3664980-0660-91 |
| sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-661 | 64980-0661-2764980-0661-3664980-0661-91 |
| sumatriptan | Sumatriptan succinate 100 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-662 | 64980-0662-2764980-0662-3664980-0662-91 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0475 | 80425-0475-01 |
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 | Caplin Steriles Limited | 65145-118 |
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | Somerset Therapeutics, LLC | 70069-804 |
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | Armas Pharmaceuticals Inc. | 72485-518 |