Prescription drug · ANDA
Eletriptan HBR NDC 72189-517
Eletriptan hydrobromide 40 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-517-06 | 72189051706 | 6 TABLET, FILM COATED in 1 CARTON (72189-517-06)Marketed from Oct 11, 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)
- Eletriptan HBR
- Generic name (nonproprietary)
- eletriptan hbr
- Active ingredients
- Eletriptan hydrobromide — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210708
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72189-517_2c4e7a35-ff54-4971-e063-6294a90ae9dfSPL ID 2c4e7a35-ff54-4971-e063-6294a90ae9dfSPL set ID 077134d1-427d-6235-e063-6394a90abcf6RxCUI 359494UNII M41W832TA3
- 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
N472189051706followed by a unit qualifier and the quantityPackage 72189-0517-06. 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)
Eletriptan hydrobromide 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 has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.
Excerpt only. Read the full label for complete information.
About NDC 72189-517
- What is NDC 72189-517?
- 72189-517 is the product NDC for Eletriptan HBR, Eletriptan hydrobromide 40 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eletriptan HBR.
- What is the active ingredient?
- Eletriptan hydrobromide.
- Who is the labeler?
- Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eletriptan HBR?
- 1 other product NDC are listed under this name. See all Eletriptan HBR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eletriptan HBR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eletriptan HBR | Eletriptan hydrobromide 40 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-439 | 72189-0439-06 |
Other NDCs under ANDA 210708
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 |
|---|---|---|---|---|
| Eletriptan Hydrobromide | Eletriptan hydrobromide 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-104 |
| Eletriptan Hydrobromide | Eletriptan hydrobromide 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-105 |
| Eletriptan Hydrobromide | Eletriptan hydrobromide 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8320 |
| Eletriptan Hydrobromide | Eletriptan hydrobromide 40 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0408 |