Prescription drug · ANDA
Sumatriptan NDC 36000-289
Sumatriptan succinate 6 mg/.5mL · Injection · Subcutaneous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36000-289-05 | 36000028905 | 5 VIAL in 1 CARTON (36000-289-05) / .5 mL in 1 VIALMarketed from Jan 19, 2023 | |
| 36000-289-10 | 36000028910 | 10 VIAL in 1 CARTON (36000-289-10) / .5 mL in 1 VIALMarketed from Jan 19, 2023 | |
| 36000-289-25 | 36000028925 | 25 VIAL in 1 CARTON (36000-289-25) / .5 mL in 1 VIALMarketed from Jan 19, 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
- Generic name (nonproprietary)
- sumatriptan
- Active ingredients
- Sumatriptan succinate — 6 mg/.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 36000
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207101
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 36000-289_62c6c207-3e07-498e-ac5c-2f6e1a632a7eSPL ID 62c6c207-3e07-498e-ac5c-2f6e1a632a7eSPL set ID d13df081-648c-44c0-9854-5a1bfe23ae89RxCUI 313165UNII J8BDZ68989UPC 0336000289016
- 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
N436000028905followed by a unit qualifier and the quantityPackage 36000-0289-05. 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 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 migrai…
Excerpt only. Read the full label for complete information.
About NDC 36000-289
- What is NDC 36000-289?
- 36000-289 is the product NDC for Sumatriptan, Sumatriptan succinate 6 mg/.5mL injection, listed with the FDA by Baxter Healthcare Corporation. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sumatriptan.
- What is the active ingredient?
- Sumatriptan succinate.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 36000. 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?
- 76 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 | 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 |
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | Caplin Steriles Limited | 65145-118 | 65145-0118-05 |