Duloxetine
- Product NDC
- 68071-3779
- 11-digit product format
- 680713779
- Labeler code
- 68071
- Product ID
- 68071-3779_2d7c292f-ed92-07c0-e063-6294a90ae805
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA090776
- Marketing category
- ANDA
- Marketing start
- 2013-12-17
- 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 |
|---|
| 68071-3779-3 | Duloxetine | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3779 | DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 1 package rows | 20250209_2d7c2a64-2ce0-f222-e063-6294a90a9056.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3779-3 | 68071377903 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68071-3779-3) | 2025-02-06 | No | No | Current |