Cymbalta
- Product NDC
- 21695-657
- 11-digit product format
- 216950657
- Labeler code
- 21695
- Product ID
- 21695-657_7db112de-473a-4407-bc1c-35d0ab748700
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA021427
- Marketing category
- NDA
- Marketing start
- 2004-08-24
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 20 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 |
|---|
| 21695-657-60 | Cymbalta | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 1 |
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 [REBEL DISTRIBUTORS CORP] | 1 | |
| Duloxetine | ACTIVE MOIETY | O5TNM5N07U | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S) | INACTIVE INGREDIENT | 24P2YXD2PW | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| Sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| Titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| Triethyl citrate | INACTIVE INGREDIENT | 8Z96QXD6UM | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-657 | CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20110726_7db112de-473a-4407-bc1c-35d0ab748700.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-657-60 | 21695065760 | 60 in 1 BOTTLE | Historical |