Fluoxetine
- Product NDC
- 66116-453
- 11-digit product format
- 661160453
- Labeler code
- 66116
- Product ID
- 66116-453_7125a96a-0e98-4984-8b57-a2e7a99b7b0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- MedVantx, Inc.
- Application
- ANDA076001
- Marketing category
- ANDA
- Marketing start
- 2012-03-20
- Marketing end
- 0000-00-00
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Serotonin 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 |
|---|
| 66116-453-30 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUOXETINE HYDROCHLORIDE | ACTIVE INGREDIENT | I9W7N6B1KJ | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
| FLUOXETINE | ACTIVE MOIETY | 01K63SUP8D | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66116-453 | FLUOXETINE CAPSULE [MEDVANTX, INC.] | 1 | Legacy NDC, 1 package rows | 20120710_7125a96a-0e98-4984-8b57-a2e7a99b7b0d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 66116-453-30 | 66116045330 | 30 in 1 BOTTLE | Historical |