Prescription drug · NDA
Imitrex (sumatriptan) NDC 0173-0737
Sumatriptan succinate 100 mg/1 · Tablet, Film coated · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0737-01 | 00173073701 | 1 CARTON in 1 CARTON (0173-0737-01) / 1 BLISTER PACK in 1 CARTON / 9 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 19, 2003 |
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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- GlaxoSmithKline LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020132
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0173-0737_5a8ad935-109c-410a-8289-fbe03c3d9643SPL ID 5a8ad935-109c-410a-8289-fbe03c3d9643SPL set ID 584abe73-8290-4484-ff8e-5890831c095eRxCUI 208450, 209169, 284460, 313160, 313161, 315223UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400173073701followed by a unit qualifier and the quantityPackage 00173-0737-01. 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 tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks. • IMITREX is not indicated for the prevention of migraine attacks. • Safety and effectiveness of IMITREX tablets have not been established for cluster headache. IMITREX is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use: •…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020132
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.