Duloxetine hydrochloride
- Product NDC
- 64725-1100
- 11-digit product format
- 647251100
- Labeler code
- 64725
- Product ID
- 64725-1100_1d38892a-0a36-46eb-9f99-7b91b7337fd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetin hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA090774
- Marketing category
- ANDA
- Marketing start
- 2013-12-11
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 64725-1100-1 | Duloxetine hydrochloride | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 2 |
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 [TYA PHARMACEUTICALS] | 2 | |
| DULOXETINE | ACTIVE MOIETY | O5TNM5N07U | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64725-1100 | DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20141110_2b6118ba-344e-4b41-89fa-c16d6e50927f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 64725-1100-1 | 64725110001 | 30 in 1 BOTTLE | Historical |