Duloxetine hydrochloride
- Product NDC
- 13668-109
- 11-digit product format
- 136680109
- Labeler code
- 13668
- Product ID
- 13668-109_eb315d7b-0f80-4192-abdc-9d158e788dc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetin hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA090774
- Marketing category
- ANDA
- Marketing start
- 2013-12-11
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DULOXETINE HYDROCHLORIDE | ACTIVE INGREDIENT | 9044SC542W | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| DULOXETINE | ACTIVE MOIETY | O5TNM5N07U | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-109 | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 16 | Legacy NDC | 20241004_b82656d8-e22e-42e5-9b97-887e6d09a68c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13668-109-01 | 13668010901 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-109-01) | 2013-12-11 | 0000-00-00 | No | No | Current |
| 13668-109-05 | 13668010905 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-109-05) | 2013-12-11 | 0000-00-00 | No | No | Current |
| 13668-109-30 | 13668010930 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-109-30) | 2013-12-11 | 0000-00-00 | No | No | Current |
| 13668-109-60 | 13668010960 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-109-60) | 2013-12-11 | 0000-00-00 | No | No | Current |
| 13668-109-74 | 13668010974 | 100 CAPSULE, DELAYED RELEASE in 1 CARTON (13668-109-74) | 2013-12-11 | 0000-00-00 | No | No | Current |