Duloxetine
- Product NDC
- 60760-462
- 11-digit product format
- 607600462
- Labeler code
- 60760
- Product ID
- 60760-462_3ef10b7a-75bb-f47e-e063-6294a90ae315
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA208706
- Marketing category
- ANDA
- Marketing start
- 2019-09-05
- 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
- 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 | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9044SC542W |
| Rxcui | 596934 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60760-462-30 | Duloxetine | 30 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 30 | | 3 |
| 60760-462-60 | Duloxetine | 60 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 60 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60760-462-30 | 60760046230 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-462-30) | 2019-09-05 | 0000-00-00 | No | No | Current |
| 60760-462-60 | 60760046260 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-462-60) | 2025-09-16 | | No | No | Historical |