DULOXETINE HYDROCHLORIDE
- Product NDC
- 46708-278
- 11-digit product format
- 467080278
- Labeler code
- 46708
- Product ID
- 46708-278_ca40a2f7-7385-41a2-92e6-0b2ddeb89ca5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA202949
- Marketing category
- ANDA
- Marketing start
- 2014-06-09
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DULOXETINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DULOXETINE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9044SC542W |
| Rxcui | 596926, 596930, 596934 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-278-10 | 2023-02-01 | C162847 | 48780-1 | f386c649-cdce-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use Initial U.S. Approval: 2004 |
| 46708-278-30 | 2023-02-01 | C162847 | 48780-1 | f386c649-cdce-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use Initial U.S. Approval: 2004 |
| 46708-278-60 | 2023-02-01 | C162847 | 48780-1 | f386c649-cdce-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use Initial U.S. Approval: 2004 |
| 46708-278-91 | 2023-02-01 | C162847 | 48780-1 | f386c649-cdce-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use Initial U.S. Approval: 2004 |
| 46708-278-10 | 2023-01-30 | C162847 | 48780-1 | f386c649-cdce-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use Initial U.S. Approval: 2004 |
| 46708-278-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-cdce-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use Initial U.S. Approval: 2004 |
| 46708-278-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-cdce-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use Initial U.S. Approval: 2004 |
| 46708-278-91 | 2023-01-30 | C162847 | 48780-1 | f386c649-cdce-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. 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 |
|---|
| 46708-278-30 | DULOXETINE HYDROCHLORIDE | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 6 |
| 46708-278-60 | DULOXETINE HYDROCHLORIDE | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 6 |
| 46708-278-90 | DULOXETINE HYDROCHLORIDE | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 6 |
| 46708-278-91 | DULOXETINE HYDROCHLORIDE | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-278 | DULOXETINE HYDROCHLORIDE (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230202_05a744a5-64ef-42d7-a19c-568be5a272d4.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 |
|---|
| 46708-278-10 | 46708027810 | 100 CAPSULE, DELAYED RELEASE in 1 CARTON (46708-278-10) | 2014-06-09 | 0000-00-00 | No | No | Current |
| 46708-278-30 | 46708027830 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-30) | 2014-06-09 | 0000-00-00 | No | No | Current |
| 46708-278-60 | 46708027860 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-60) | 2014-06-09 | 0000-00-00 | No | No | Current |
| 46708-278-90 | 46708027890 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-90) | 2014-06-09 | | No | No | Historical |
| 46708-278-91 | 46708027891 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-91) | 2026-04-09 | 0000-00-00 | No | No | Current |