Cymbalta
- Product NDC
- 43353-303
- 11-digit product format
- 433530303
- Labeler code
- 43353
- Product ID
- 43353-303_061f7a95-4302-49fa-8ecf-9f9a55ef0f31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA021427
- Marketing category
- NDA
- Marketing start
- 2004-08-24
- 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
- 2019-12-31
- 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 |
|---|
| 43353-303-19 | Cymbalta | 3060 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 3060 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Duloxetine hydrochloride | ACTIVE INGREDIENT | 9044SC542W | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| Duloxetine | ACTIVE MOIETY | O5TNM5N07U | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S) | INACTIVE INGREDIENT | 24P2YXD2PW | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| Sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| Titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| Triethyl citrate | INACTIVE INGREDIENT | 8Z96QXD6UM | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-303 | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC, 1 package rows | 20140429_88b2461b-4a44-4899-b63d-bcecc754266f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-303-19 | 43353030319 | 3060 in 1 BOTTLE, PLASTIC | Historical |