Prescription drug · ANDA
Milnacipran Hydrochloride NDC 31722-846
Milnacipran hydrochloride 12.5 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-846-32 | 31722084632 | 10 BLISTER PACK in 1 CARTON (31722-846-32) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 19, 2026 | |
| 31722-846-60 | 31722084660 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-846-60)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 — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205147
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-846_4cbf720f-9cdf-7cfe-e063-6394a90a6d84SPL ID 4cbf720f-9cdf-7cfe-e063-6394a90a6d84SPL set ID 99efa59a-8458-4e04-8cb1-20abfc179228RxCUI 833135, 833141, 833144, 833147, 833150UNII RNZ43O5WW5UPC 0331722846608, 0331722847605, 0331722849609, 0331722848602
- 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
N431722084632followed by a unit qualifier and the quantityPackage 31722-0846-32. 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 tablets are indicated for the management of fibromyalgia. Milnacipran hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)] . Milnacipran hydrochloride tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia (1) . Milnacipran hydrochloride tablets are not approved for use in pediatric patients (1) .
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205147
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 25 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-847 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 50 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-848 |
| Milnacipran Hydrochloride | Milnacipran hydrochloride 100 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-849 |
| Milnacipran Hydrochloride | — | Kit | Camber Pharmaceuticals, Inc. | 31722-880 |