Milnacipran Hydrochloride
- Product NDC
- 51991-036
- 11-digit product format
- 519910036
- Labeler code
- 51991
- Product ID
- 51991-036_06af9883-25a1-4d2f-849c-a32e43a1324e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Milnacipran Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA205071
- Marketing category
- ANDA
- Marketing start
- 2026-03-19
- Substance
- MILNACIPRAN HYDROCHLORIDE
- Active strength
- 50 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
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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RNZ43O5WW5 |
| Rxcui | 833135, 833141, 833144, 833147 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51991-036-06 | Milnacipran Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51991-036-06 | 51991003606 | 60 TABLET in 1 BOTTLE (51991-036-06) | 60 tablet | 2026-03-19 | No | No | Current |