Prescription drug · ANDA
Eletriptan Hydrobromide NDC 0378-4287
Eletriptan hydrobromide 20 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-4287-85 | 00378428785 | 1 BLISTER PACK in 1 CARTON (0378-4287-85) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4287-32)Marketed from Aug 15, 2017 |
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)
- Eletriptan Hydrobromide
- Generic name (nonproprietary)
- eletriptan hydrobromide
- Active ingredients
- Eletriptan hydrobromide — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205152
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0378-4287_cba8e2c4-eb4b-49c7-83be-d5cfb58b23d9SPL ID cba8e2c4-eb4b-49c7-83be-d5cfb58b23d9SPL set ID 20276f5c-f2d6-469f-9a1b-aa254a1db21cRxCUI 359493, 359494UNII M41W832TA3UPC 0303784287859
- 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
N400378428785followed by a unit qualifier and the quantityPackage 00378-4287-85. 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. Eletriptan hydrobromide tablets are a serotonin (5-HT 1B/1D ) recepto…
Excerpt only. Read the full label for complete information.
About NDC 0378-4287
- What is NDC 0378-4287?
- 0378-4287 is the product NDC for Eletriptan Hydrobromide, Eletriptan hydrobromide 20 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eletriptan Hydrobromide.
- What is the active ingredient?
- Eletriptan hydrobromide.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 Hydrobromide?
- 16 other product NDCs are listed under this name. See all Eletriptan Hydrobromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eletriptan Hydrobromide 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 Hydrobromide | Eletriptan hydrobromide 20 mg/1 | Tablet, Film coatedOral | Apnar Pharma LP | 24689-167 | 24689-0167-01 |
| Eletriptan Hydrobromide | Eletriptan hydrobromide 40 mg/1 | Tablet, Film coatedOral | Apnar Pharma LP | 24689-168 | 24689-0168-01 |
| Eletriptan hydrobromide | Eletriptan hydrobromide 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-443 | 31722-0443-31 |
| Eletriptan hydrobromide | Eletriptan hydrobromide 40 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-444 | 31722-0444-3131722-0444-33 |
| Eletriptan Hydrobromide | Eletriptan hydrobromide 40 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0408 | 80425-0408-01 |
| Eletriptan Hydrobromide | Eletriptan hydrobromide 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-104 | 59651-0104-69 |
| Eletriptan Hydrobromide | Eletriptan hydrobromide 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-105 | 59651-0105-6959651-0105-93 |
| Eletriptan Hydrobromide | Eletriptan hydrobromide 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8320 | 63629-8320-0163629-8320-02 |
| Eletriptan Hydrobromide | Eletriptan hydrobromide 40 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-4288 | 00378-4288-0800378-4288-85 |
| Eletriptan Hydrobromide | Eletriptan hydrobromide 20 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8310 | 00093-8310-18 |
Other NDCs under ANDA 205152
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 40 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-4288 |