Prescription drug · NDA
Fetzima (Levomilnacipran hydrochloride) NDC 0456-2212
Levomilnacipran hydrochloride 120 mg/1 · Capsule, Extended release · Oral · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0456-2212-30 | 00456221230 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2212-30)Marketed from Jul 25, 2013 | |
| 0456-2212-90 | 00456221290 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2212-90)Marketed from Jul 25, 2013 |
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)
- Fetzima
- Generic name (nonproprietary)
- levomilnacipran hydrochloride
- Active ingredients
- Levomilnacipran hydrochloride — 120 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Allergan, Inc.NDC labeler code 0456
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204168
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0456-2212_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57SPL ID b4f9c587-d1eb-462b-bad2-ed0ce6d76c57SPL set ID f371258d-91b3-4b6a-ac99-434a1964c3afRxCUI 1433217, 1433223, 1433227, 1433229, 1433233, 1433235, 1433239, 1433241, 1433249, 1433250, 2636817, 2636818UNII 371U2ZK31UUPC 0304562240301
- 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
N400456221230followed by a unit qualifier and the quantityPackage 00456-2212-30. 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)
FETZIMA ® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )]. Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established. FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults ( 1 ). Limitation of Use : FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 0456-2212
- What is NDC 0456-2212?
- 0456-2212 is the product NDC for Fetzima (levomilnacipran hydrochloride), Levomilnacipran hydrochloride 120 mg/1 capsule, extended release, listed with the FDA by Allergan, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fetzima (Levomilnacipran hydrochloride).
- What is the active ingredient?
- Levomilnacipran hydrochloride.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0456. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fetzima?
- 5 other product NDCs are listed under this name. See all Fetzima NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fetzima products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fetzimalevomilnacipran hydrochloride | — | KitOral | Allergan, Inc. | 0456-2200 | 00456-2200-07 |
| Fetzimalevomilnacipran hydrochloride | — | KitOral | Allergan, Inc. | 0456-2202 | 00456-2202-28 |
| Fetzimalevomilnacipran hydrochloride | Levomilnacipran hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Allergan, Inc. | 0456-2220 | 00456-2220-0700456-2220-30 |
| Fetzimalevomilnacipran hydrochloride | Levomilnacipran hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Allergan, Inc. | 0456-2240 | 00456-2240-3000456-2240-90 |
| Fetzimalevomilnacipran hydrochloride | Levomilnacipran hydrochloride 80 mg/1 | Capsule, Extended releaseOral | Allergan, Inc. | 0456-2280 | 00456-2280-3000456-2280-90 |
Other NDCs under NDA 204168
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 |
|---|---|---|---|---|
| Fetzimalevomilnacipran hydrochloride | — | KitOral | Allergan, Inc. | 0456-2200 |
| Fetzimalevomilnacipran hydrochloride | — | KitOral | Allergan, Inc. | 0456-2202 |
| Fetzimalevomilnacipran hydrochloride | Levomilnacipran hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Allergan, Inc. | 0456-2220 |
| Fetzimalevomilnacipran hydrochloride | Levomilnacipran hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Allergan, Inc. | 0456-2240 |
| Fetzimalevomilnacipran hydrochloride | Levomilnacipran hydrochloride 80 mg/1 | Capsule, Extended releaseOral | Allergan, Inc. | 0456-2280 |