Duloxetine
- Product NDC
- 68071-3766
- 11-digit product format
- 680713766
- Labeler code
- 68071
- Product ID
- 68071-3766_2b61d5b5-490b-5494-e063-6294a90a3fa1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA208706
- Marketing category
- ANDA
- Marketing start
- 2017-03-16
- 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 |
|---|
| 68071-3766-9 | Duloxetine | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3766 | DULOXETINE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20250112_2b61c261-d7f2-4f9d-e063-6294a90acc24.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3766-9 | 68071376609 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3766-9) | 2025-01-10 | No | No | Current |