Prescription drug · NDA
Imitrex (Sumatriptan) NDC 0173-0478
Sumatriptan succinate 6 mg/.5mL · Injection · Subcutaneous · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0478-00 | 00173047800 | 2 SYRINGE in 1 CARTON (0173-0478-00) / .5 mL in 1 SYRINGEMarketed from Jan 27, 1997 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Imitrex
- Generic name (nonproprietary)
- sumatriptan
- Active ingredients
- Sumatriptan succinate — 6 mg/.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020080
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0173-0478_9770a6f8-f25f-48e7-a513-4a26bb43b5c1SPL ID 9770a6f8-f25f-48e7-a513-4a26bb43b5c1SPL set ID fee7d073-0b99-48f2-7985-0d8cf970894bRxCUI 758523, 860088, 1657160, 1657173UNII 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
N400173047800followed by a unit qualifier and the quantityPackage 00173-0478-00. 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)
IMITREX 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 IMITREX injection, reconsider the diagnosis before IMITREX injection is administered to treat any subsequent attacks. • IMITREX injection is not indicated for the prevention of migraine or cluster headache attacks. IMITREX injection is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for: • Acute treatment of migraine with or without a…
Excerpt only. Read the full label for complete information.
About NDC 0173-0478
- What is NDC 0173-0478?
- 0173-0478 is the product NDC for Imitrex (sumatriptan), Sumatriptan succinate 6 mg/.5mL injection, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imitrex (Sumatriptan).
- What is the active ingredient?
- Sumatriptan succinate.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imitrex?
- 5 other product NDCs are listed under this name. See all Imitrex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imitrex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imitrexsumatriptan | Sumatriptan succinate 4 mg/.5mL | InjectionSubcutaneous | GlaxoSmithKline LLC | 0173-0739 | 00173-0739-0000173-0739-02 |
| Imitrexsumatriptan | Sumatriptan succinate 100 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0737 | 00173-0737-01 |
| Imitrexsumatriptan | Sumatriptan succinate 25 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0735 | 00173-0735-00 |
| Imitrexsumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0736 | 00173-0736-01 |
| Imitrexsumatriptan | Sumatriptan succinate 6 mg/.5mL | InjectionSubcutaneous | GlaxoSmithKline LLC | 0173-0479 | 00173-0479-00 |
Other NDCs under NDA 020080
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 |
|---|---|---|---|---|
| Imitrexsumatriptan | Sumatriptan succinate 6 mg/.5mL | InjectionSubcutaneous | GlaxoSmithKline LLC | 0173-0479 |
| Imitrexsumatriptan | Sumatriptan succinate 4 mg/.5mL | InjectionSubcutaneous | GlaxoSmithKline LLC | 0173-0739 |