Duloxetine
- Product NDC
- 67046-1598
- 11-digit product format
- 670461598
- Labeler code
- 67046
- Product ID
- 67046-1598_47f98f5b-1e73-b33a-e063-6294a90a9a25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA090694
- Marketing category
- ANDA
- Marketing start
- 2025-09-22
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 60 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
- Duloxetine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DULOXETINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9044SC542W |
| Rxcui | 596934 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1598-3 | Duloxetine | 30 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 30 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1598-3 | 67046159803 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-1598-3) | 2025-09-22 | No | No | Historical |