Duloxetine D/R
- Product NDC
- 72189-634
- 11-digit product format
- 721890634
- Labeler code
- 72189
- Product ID
- 72189-634_3ac53025-8a9a-31de-e063-6294a90a53d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine D/R
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA090694
- Marketing category
- ANDA
- Marketing start
- 2025-07-25
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 20 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 D/R
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DULOXETINE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9044SC542W |
| Rxcui | 596926 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-634-30 | Duloxetine D/R | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-634-30 | 72189063430 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-634-30) | 2025-07-25 | No | No | Historical |