Milnacipran Hydrochloride
- Product NDC
- 33342-369
- 11-digit product format
- 333420369
- Labeler code
- 33342
- Product ID
- 33342-369_52ad5462-ed80-417a-964f-56ef1fdce3f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Milnacipran Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA210944
- Marketing category
- ANDA
- Marketing start
- 2026-09-15
- Substance
- MILNACIPRAN HYDROCHLORIDE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Milnacipran Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MILNACIPRAN HYDROCHLORIDE | 12.5 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-369-09 | 33342036909 | 60 TABLET in 1 BOTTLE (33342-369-09) | 60 tablet | 2026-09-15 | No | No | Current |
| 33342-369-12 | 33342036912 | 10 BLISTER PACK in 1 CARTON (33342-369-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2026-09-15 | No | No | Current |
| 33342-369-15 | 33342036915 | 500 TABLET in 1 BOTTLE (33342-369-15) | 500 tablet | 2026-09-15 | No | No | Current |