Prescription drug · NDA AUTHORIZED GENERIC
Milnacipran Hydrochloride NDC 68462-765
Milnacipran hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-765-60 | 68462076560 | 60 TABLET, FILM COATED in 1 BOTTLE (68462-765-60)Marketed from Mar 19, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Milnacipran Hydrochloride
- Generic name (nonproprietary)
- milnacipran hydrochloride
- Active ingredients
- Milnacipran hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022256
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68462-765_97a7eb14-fa99-40e4-91c2-be5b34f5e203SPL ID 97a7eb14-fa99-40e4-91c2-be5b34f5e203SPL set ID b66b1850-0d2a-41d6-b0ad-c676166394c7RxCUI 833135, 833141, 833144, 833147UNII RNZ43O5WW5UPC 0368462766606, 0368462763605, 0368462765609, 0368462764602
- 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
N468462076560followed by a unit qualifier and the quantityPackage 68462-0765-60. 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)
Milnacipran hydrochloride is indicated for the management of fibromyalgia. Milnacipran hydrochloride is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . • Milnacipran hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia ( 1 ). • Milnacipran hydrochloride is not approved for use in pediatric patients ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 68462-765
- What is NDC 68462-765?
- 68462-765 is the product NDC for Milnacipran Hydrochloride, Milnacipran hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Milnacipran Hydrochloride.
- What is the active ingredient?
- Milnacipran hydrochloride.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Milnacipran Hydrochloride?
- 16 other product NDCs are listed under this name. See all Milnacipran Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Milnacipran Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Milnacipran Hydrochloride | Milnacipran hydrochloride 12.5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-369 | 33342-0369-0933342-0369-1233342-0369-15 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 100 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-372 | 33342-0372-0933342-0372-1233342-0372-15 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 25 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-370 | 33342-0370-0933342-0370-1233342-0370-15 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 50 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-371 | 33342-0371-0933342-0371-1233342-0371-15 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 12.5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-034 | 51991-0034-06 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 50 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-036 | 51991-0036-06 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 100 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-037 | 51991-0037-06 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 25 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-876 | 51991-0876-06 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 50 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-848 | 31722-0848-3231722-0848-60 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 12.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-846 | 31722-0846-3231722-0846-60 |
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 |
|---|---|---|---|---|
| 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 |
| Savellamilnacipran hydrochloride | Milnacipran hydrochloride 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4626 |
| 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 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 |