DULOXETINE HYDROCHLORIDE
- Product NDC
- 61919-042
- 11-digit product format
- 619190042
- Labeler code
- 61919
- Product ID
- 61919-042_f2024175-88ef-a7ed-e053-2995a90a61cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DULOXETINE HYDROCHLORIDE
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA203088
- 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
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 |
|---|
| 61919-042-30 | DULOXETINE HYDROCHLORIDE | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 30 | | 9 |
| 61919-042-60 | DULOXETINE HYDROCHLORIDE | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 60 | | 9 |
| 61919-042-90 | DULOXETINE HYDROCHLORIDE | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 90 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DULOXETINE HYDROCHLORIDE | ACTIVE INGREDIENT | 9044SC542W | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| DULOXETINE | ACTIVE MOIETY | O5TNM5N07U | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-042 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX] | 9 | Legacy NDC, 2 package rows | 20230331_d8154451-179f-482f-bce0-1e39152f03b1.zip |
| 61919-042 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT_RX] | 2 | Legacy NDC, 1 package rows | 20200121_903cdf86-c319-1d65-e053-2995a90ac6b7.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 |
|---|
| 61919-042-30 | 61919004230 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (61919-042-30) | 2015-07-15 | 0000-00-00 | No | No | Current |
| 61919-042-60 | 61919004260 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (61919-042-60) | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-042-90 | 61919004290 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (61919-042-90) | 2019-08-16 | 0000-00-00 | No | No | Current |