Duloxetine Hydrochloride
- Product NDC
- 63187-172
- 11-digit product format
- 631870172
- Labeler code
- 63187
- Product ID
- 63187-172_58a38000-a494-41ed-9491-a39e589f59b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine Hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202045
- Marketing category
- ANDA
- Marketing start
- 2014-06-13
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| DULOXETINE | ACTIVE MOIETY | O5TNM5N07U | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| DIBUTYL SEBACATE | INACTIVE INGREDIENT | 4W5IH7FLNY | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| METHYLCELLULOSE (15 MPA.S) | INACTIVE INGREDIENT | NPU9M2E6L8 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| POLYVINYL ACETATE PHTHALATE | INACTIVE INGREDIENT | 58QVG85GW3 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) | INACTIVE INGREDIENT | 9Q5W5G6461 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-172 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 4 | Legacy NDC | 20191121_b3c1561b-dd87-4338-a09f-ff4be5800cee.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-172-30 | 63187017230 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-172-30) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-172-60 | 63187017260 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-172-60) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-172-90 | 63187017290 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-172-90) | 2018-12-01 | 0000-00-00 | No | No | Current |