Duloxetine
- Product NDC
- 50090-7784
- 11-digit product format
- 500907784
- Labeler code
- 50090
- Product ID
- 50090-7784_ff8516a1-b0de-4bd3-9945-523089b42128
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090694
- Marketing category
- ANDA
- Marketing start
- 2013-12-11
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 30 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Duloxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DULOXETINE HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9044SC542W |
| Rxcui | 596930 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7784-0 | Duloxetine | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 14 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7784-0 | 50090778400 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7784-0) | 2025-11-21 | No | No | Historical |