DULOXETINE
- Product NDC
- 63187-720
- 11-digit product format
- 631870720
- Labeler code
- 63187
- Product ID
- 63187-720_1f36294a-3092-46a3-9d23-9d0c1a3e6254
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DULOXETINE HYDROCHLORIDE
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203088
- Marketing category
- ANDA
- Marketing start
- 2014-06-11
- 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
- Brand name suffix
- DELAYED-RELEASE
- 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 |
|---|
| 63187-720-30 | DULOXETINEDELAYED-RELEASE | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 30 | | 3 |
| 63187-720-60 | DULOXETINEDELAYED-RELEASE | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 60 | | 3 |
| 63187-720-90 | DULOXETINEDELAYED-RELEASE | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-720 | DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20191121_407b62b9-5b32-4bac-a2b0-7df499279248.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 |
|---|
| 63187-720-30 | 63187072030 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-720-30) | 2016-06-01 | 0000-00-00 | No | No | Current |
| 63187-720-60 | 63187072060 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-720-60) | 2016-06-01 | 0000-00-00 | No | No | Current |
| 63187-720-90 | 63187072090 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-720-90) | 2016-06-01 | 0000-00-00 | No | No | Current |