Prescription drug · ANDA
Almotriptan Malate NDC 0093-5261
Almotriptan malate 12.5 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-5261-29 | 00093526129 | 12 BLISTER PACK in 1 CARTON (0093-5261-29) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-5261-19)Marketed from Jul 7, 2015 |
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)
- Almotriptan Malate
- Generic name (nonproprietary)
- almotriptan malate
- Active ingredients
- Almotriptan malate — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078027
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0093-5261_3c9afddb-516b-43a3-9a28-9a3b3aca6340SPL ID 3c9afddb-516b-43a3-9a28-9a3b3aca6340SPL set ID c41a4579-9db0-402b-81b1-0adf5b3978c3RxCUI 284204, 284205UNII PJP312605E
- 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
N400093526129followed by a unit qualifier and the quantityPackage 00093-5261-29. 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)
Almotriptan malate tablets are a 5HT 1B/1D receptor agonist (triptan) indicated for: Acute treatment of migraine attacks in adults with a history of migraine with or without aura ( 1.1 ) Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more ( 1.1 ) Important limitations: Use only after a clear diagnosis of migraine has been established ( 1.2 ) In adolescents age 12 to 17 years, efficacy of almotriptan malate tablets on migraine-associated symptoms was not established ( 1.2 ) Not intended for the prophylactic therapy of migraine ( 1.2 ) Not indicated for the tre…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078027
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 |
|---|---|---|---|---|
| Almotriptan Malate | Almotriptan malate 6.25 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5260 |