Prescription drug · NDA
Savella (Milnacipran hydrochloride) NDC 55154-4626
Milnacipran hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-4626-8 | 55154462608 | 1920 TABLET, FILM COATED in 1 BOTTLE (55154-4626-8)Marketed from Apr 17, 2009 |
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)
- Savella
- Generic name (nonproprietary)
- milnacipran hydrochloride
- Active ingredients
- Milnacipran hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cardinal Health 107, LLCNDC labeler code 55154
- 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 55154-4626_29696af7-4f76-41f7-b2b0-c766bd7b21aeSPL ID 29696af7-4f76-41f7-b2b0-c766bd7b21aeSPL set ID 8b720a1e-034b-4583-b80d-105a794cce74RxCUI 833144, 833146UNII 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
N455154462608followed by a unit qualifier and the quantityPackage 55154-4626-08. 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.
About NDC 55154-4626
- What is NDC 55154-4626?
- 55154-4626 is the product NDC for Savella (milnacipran hydrochloride), Milnacipran hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Savella (Milnacipran hydrochloride).
- What is the active ingredient?
- Milnacipran hydrochloride.
- Who is the labeler?
- Cardinal Health 107, LLC, NDC labeler code 55154. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Savella?
- 5 other product NDCs are listed under this name. See all Savella NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Savella products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Savellamilnacipran hydrochloride | — | KitOral | Allergan, Inc. | 0456-1500 | 00456-1500-55 |
| Savellamilnacipran hydrochloride | Milnacipran hydrochloride 100 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-1510 | 00456-1510-60 |
| Savellamilnacipran hydrochloride | Milnacipran hydrochloride 12.5 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-1512 | 00456-1512-60 |
| Savellamilnacipran hydrochloride | Milnacipran hydrochloride 25 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-1525 | 00456-1525-60 |
| Savellamilnacipran hydrochloride | Milnacipran hydrochloride 50 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-1550 | 00456-1550-60 |
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 |
|---|---|---|---|---|
| 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 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 100 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-766 |
| 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 25 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-1525 |
| Savellamilnacipran hydrochloride | Milnacipran hydrochloride 50 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-1550 |