Duloxetine
- Product NDC
- 53002-1561
- 11-digit product format
- 530021561
- Labeler code
- 53002
- Product ID
- 53002-1561_f3775976-1ead-479f-be96-018bc1ba0b5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA208706
- Marketing category
- ANDA
- Marketing start
- 2017-03-16
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1561-3 | Duloxetine | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1561 | DULOXETINE CAPSULE, DELAYED RELEASE [RPK PHARMACEUTICALS, INC.] | 8 | Legacy NDC, 1 package rows | 20230609_556d7dd0-0e3d-4f70-9786-e546a43ef539.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 |
|---|
| 53002-1561-3 | 53002156103 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53002-1561-3) | 2017-09-01 | 0000-00-00 | No | No | Current |