Duloxetine
- Product NDC
- 65841-774
- 11-digit product format
- 658410774
- Labeler code
- 65841
- Product ID
- 65841-774_f58fa578-b934-4fe6-8951-6524960aa868
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Cadila Healthcare Limited
- Application
- ANDA090728
- Marketing category
- ANDA
- Marketing start
- 2014-02-15
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 20 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 |
|---|
| 65841-774-06 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-49cb-60a7-e053-dbdaa90a05bd | 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 USP for oral use. Initial U.S. Approval: 2004 |
| 65841-774-10 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-49cb-60a7-e053-dbdaa90a05bd | 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 USP for oral use. Initial U.S. Approval: 2004 |
| 65841-774-14 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-49cb-60a7-e053-dbdaa90a05bd | 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 USP for oral use. Initial U.S. Approval: 2004 |
| 65841-774-16 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-49cb-60a7-e053-dbdaa90a05bd | 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 USP 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 |
|---|
| 65841-774-06 | Duloxetine | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 1 |
| 65841-774-10 | Duloxetine | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 1 |
| 65841-774-14 | Duloxetine | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 1 |
| 65841-774-16 | Duloxetine | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DULOXETINE HYDROCHLORIDE | ACTIVE INGREDIENT | 9044SC542W | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| DULOXETINE | ACTIVE MOIETY | O5TNM5N07U | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) | INACTIVE INGREDIENT | G4U024CQK6 | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-774 | DULOXETINE CAPSULE, DELAYED RELEASE [CADILA HEALTHCARE LIMITED] | 1 | Legacy NDC, 4 package rows | 20140215_5e7fad97-2e62-4f1c-92aa-ea1318c3db09.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 65841-774-06 | 65841077406 | 30 in 1 BOTTLE | Historical |
| 65841-774-10 | 65841077410 | 1000 in 1 BOTTLE | Historical |
| 65841-774-14 | 65841077414 | 60 in 1 BOTTLE | Historical |
| 65841-774-16 | 65841077416 | 90 in 1 BOTTLE | Historical |