Duloxetine
- Product NDC
- 67046-1451
- 11-digit product format
- 670461451
- Labeler code
- 67046
- Product ID
- 67046-1451_2d94184b-be29-ca5f-e063-6294a90afd1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA208706
- Marketing category
- ANDA
- Marketing start
- 2025-02-07
- 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
- 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 |
|---|
| 67046-1451-3 | Duloxetine | 30 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-1451 | DULOXETINE CAPSULE, DELAYED RELEASE [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250210_2d942e38-90d4-de39-e063-6294a90a9822.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1451-3 | 67046145103 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-1451-3) | 2025-02-07 | No | No | Historical |