Duloxetine HCL
- Product NDC
- 80425-0012
- 11-digit product format
- 804250012
- Labeler code
- 80425
- Product ID
- 80425-0012_2a984d4a-2346-2be3-e063-6294a90ad5d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine HCL
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA203197
- Marketing category
- ANDA
- Marketing start
- 2012-05-01
- 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 HCL
- Brand name suffix
- DR
- 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 |
|---|
| 80425-0012-1 | Duloxetine HCLDR | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 11 |
| 80425-0012-2 | Duloxetine HCLDR | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0012 | DULOXETINE HCL DR (DULOXETINE HCL) CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250101_af6f8abd-19ec-69e4-e053-2a95a90ab69e.zip |
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 |
|---|
| 80425-0012-1 | 80425001201 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0012-1) | 2020-09-25 | 0000-00-00 | No | No | Current |
| 80425-0012-2 | 80425001202 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0012-2) | 2020-09-25 | 0000-00-00 | No | No | Current |