DULOXETINE
- Product NDC
- 61919-483
- 11-digit product format
- 619190483
- Labeler code
- 61919
- Product ID
- 61919-483_f2147260-be6f-3f01-e053-2995a90ac7b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DULOXETINE
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA090745
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 60 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
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DULOXETINE HYDROCHLORIDE | ACTIVE INGREDIENT | 9044SC542W | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| DULOXETINE | ACTIVE MOIETY | O5TNM5N07U | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-483 | DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX] | 4 | Legacy NDC | 20230113_800192cd-c01e-4790-a2d0-5005c1326b04.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61919-483-30 | 61919048330 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-483-30) | 2015-01-01 | 0000-00-00 | No | No | Current |