Prescription drug · NDA
Savella (milnacipran hydrochloride) NDC 0456-1525
Milnacipran hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0456-1525-60 | 00456152560 | 60 TABLET, FILM COATED in 1 BOTTLE (0456-1525-60)Marketed from Apr 17, 2009 |
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)
- Savella
- Generic name (nonproprietary)
- milnacipran hydrochloride
- Active ingredients
- Milnacipran hydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Allergan, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022256
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0456-1525_d6462f8d-f32a-4157-bc50-9831da50c453SPL ID d6462f8d-f32a-4157-bc50-9831da50c453SPL set ID 16a4a314-f97e-4e91-95e9-576a3773d284RxCUI 833135, 833139, 833141, 833143, 833144, 833146, 833147, 833149, 833150, 833151UNII RNZ43O5WW5
- Pharmacologic class
- Serotonin and Norepinephrine Reuptake Inhibitor
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
N400456152560followed by a unit qualifier and the quantityPackage 00456-1525-60. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
SAVELLA is indicated for the management of fibromyalgia. SAVELLA is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . SAVELLA ® is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia ( 1 ). SAVELLA is not approved for use in pediatric patients ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022256
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 |
|---|---|---|---|---|
| Savellamilnacipran hydrochloride | — | KitOral | Allergan, Inc. | 0456-1500 |
| Savellamilnacipran hydrochloride | Milnacipran hydrochloride 100 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-1510 |
| Savellamilnacipran hydrochloride | Milnacipran hydrochloride 12.5 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-1512 |
| Savellamilnacipran hydrochloride | Milnacipran hydrochloride 50 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-1550 |
| Savellamilnacipran hydrochloride | Milnacipran hydrochloride 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4626 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 100 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-766 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 12.5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-763 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-764 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 50 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-765 |