Prescription drug · ANDA
Milnacipran HCl NDC 65162-092
Milnacipran hydrochloride 25 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-092-06 | 65162009206 | 60 TABLET in 1 BOTTLE (65162-092-06)Marketed from Jan 31, 2014 |
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 HCl
- Generic name (nonproprietary)
- milnacipran hcl
- Active ingredients
- Milnacipran hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205081
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-092_a56fc239-2e5e-4aa0-bfdf-084d76e27cb9SPL ID a56fc239-2e5e-4aa0-bfdf-084d76e27cb9
- 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
N465162009206followed by a unit qualifier and the quantityPackage 65162-0092-06. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 65162-092
- What is NDC 65162-092?
- 65162-092 is the product NDC for Milnacipran HCl, Milnacipran hydrochloride 25 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Milnacipran HCl.
- What is the active ingredient?
- Milnacipran hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 HCl?
- 3 other product NDCs are listed under this name. See all Milnacipran HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Milnacipran HCl 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 HCl | Milnacipran hydrochloride 12.5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-091 | 65162-0091-06 |
| Milnacipran HCl | Milnacipran hydrochloride 50 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-093 | 65162-0093-0665162-0093-50 |
| Milnacipran HCl | Milnacipran hydrochloride 100 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-094 | 65162-0094-0665162-0094-50 |
Other NDCs under ANDA 205081
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 HCl | Milnacipran hydrochloride 12.5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-091 |
| Milnacipran HCl | Milnacipran hydrochloride 50 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-093 |
| Milnacipran HCl | Milnacipran hydrochloride 100 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-094 |