Prescription drug · ANDA
Frovatriptan (Frovatriptan succinate) NDC 69238-1539
Frovatriptan succinate 2.5 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1539-9 | 69238153909 | 1 BLISTER PACK in 1 CARTON (69238-1539-9) / 9 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 13, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Frovatriptan
- Generic name (nonproprietary)
- frovatriptan succinate
- Active ingredients
- Frovatriptan succinate — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211292
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69238-1539_b44b534c-17a5-4a71-a3e5-7d98adb4cdd1SPL ID b44b534c-17a5-4a71-a3e5-7d98adb4cdd1SPL set ID 94b996dc-ddc4-41ce-9a9f-3d91cb187473RxCUI 349462UNII D28J6W18HYUPC 0369238153996
- 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
N469238153909followed by a unit qualifier and the quantityPackage 69238-1539-09. 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)
Frovatriptan succinate 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 for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks. Frovatriptan succinate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache. Frovatriptan succinate is a serotonin (5-HT 1B / 1D ) receptor agonist (triptan…
Excerpt only. Read the full label for complete information.
About NDC 69238-1539
- What is NDC 69238-1539?
- 69238-1539 is the product NDC for Frovatriptan (frovatriptan succinate), Frovatriptan succinate 2.5 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Frovatriptan (Frovatriptan succinate).
- What is the active ingredient?
- Frovatriptan succinate.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Frovatriptan?
- 1 other product NDC are listed under this name. See all Frovatriptan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Frovatriptan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Frovatriptanfrovatriptan succinate | Frovatriptan succinate 2.5 mg/1 | Tablet, Film coatedOral | Ingenus Pharmaceuticals, LLC | 50742-299 | 50742-0299-09 |