Duloxetine
- Product NDC
- 63629-8748
- 11-digit product format
- 636298748
- Labeler code
- 63629
- Product ID
- 63629-8748_b9f90234-c0e9-4c82-8787-d441d2181384
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090776
- Marketing category
- ANDA
- Marketing start
- 2013-12-17
- 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
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8748-1 | Duloxetine | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 30 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8748 | DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 1 package rows | 20240601_726b3c3e-8266-4a8a-a426-899cecd4f87e.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 |
|---|
| 63629-8748-1 | 63629874801 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-8748-1) | 2013-12-17 | 0000-00-00 | No | No | Current |