Duloxetine
- Product NDC
- 71610-743
- 11-digit product format
- 716100743
- Labeler code
- 71610
- Product ID
- 71610-743_3724601a-53f8-5bd3-e063-6394a90a98a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DULOXETINE HYDROCHLORIDE
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA203088
- Marketing category
- ANDA
- Marketing start
- 2014-06-11
- 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
- Brand name suffix
- Delayed-Release
- 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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-743-30 | 71610074330 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-30) | 2023-10-16 | No | No | Historical |
| 71610-743-53 | 71610074353 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-53) | 2023-10-16 | No | No | Historical |
| 71610-743-60 | 71610074360 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-60) | 2023-10-16 | No | No | Historical |
| 71610-743-74 | 71610074374 | 500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-74) | 2025-06-05 | No | No | Historical |
| 71610-743-80 | 71610074380 | 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-743-80) | 2024-03-20 | No | No | Historical |