duloxetine
- Product NDC
- 69097-299
- 11-digit product format
- 690970299
- Labeler code
- 69097
- Product ID
- 69097-299_43bebed3-9eea-474d-81f3-03b72289cf55
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA202336
- Marketing category
- ANDA
- Marketing start
- 2015-12-05
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 69097-299-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cea1-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004 |
| 69097-299-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cea1-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004 |
| 69097-299-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cea1-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004 |
| 69097-299-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cea1-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-299-02 | duloxetine | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 2 |
| 69097-299-03 | duloxetine | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 2 |
| 69097-299-05 | duloxetine | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 2 |
| 69097-299-15 | duloxetine | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-299 | DULOXETINE CAPSULE, DELAYED RELEASE [CIPLA USA INC.] | 2 | Legacy NDC, 4 package rows | 20160426_5ed8f173-e3da-4baa-a341-a79a05e2c4cb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 69097-299-02 | 69097029902 | 30 in 1 BOTTLE | Historical |
| 69097-299-03 | 69097029903 | 60 in 1 BOTTLE | Historical |
| 69097-299-05 | 69097029905 | 90 in 1 BOTTLE | Historical |
| 69097-299-15 | 69097029915 | 1000 in 1 BOTTLE | Historical |