Fluoxetine
- Product NDC
- 0093-7198
- 11-digit product format
- 000937198
- Labeler code
- 0093
- Product ID
- 0093-7198_61c76dc7-bc11-4dec-bf02-b4ef5474cbb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA075452
- Marketing category
- ANDA
- Marketing start
- 2002-01-30
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluoxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOXETINE HYDROCHLORIDE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 313989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-7198-01 | Fluoxetine | 100 in 1 BOTTLE | CAPSULE | 100 | | 29 |
| 0093-7198-05 | Fluoxetine | 500 in 1 BOTTLE | CAPSULE | 500 | | 29 |
| 0093-7198-56 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 29 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-7198 | FLUOXETINE CAPSULE [TEVA PHARMACEUTICALS USA, INC.] | 27 | Current NDC, Legacy NDC, 3 package rows | 20240918_369dbfba-9de4-433c-8680-2ec047b8f8d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-7198-01 | 00093719801 | 100 CAPSULE in 1 BOTTLE (0093-7198-01) | 100 capsule | 2008-09-08 | 0000-00-00 | No | No | Current |
| 0093-7198-05 | 00093719805 | 500 CAPSULE in 1 BOTTLE (0093-7198-05) | 500 capsule | 2008-09-23 | 0000-00-00 | No | No | Current |
| 0093-7198-56 | 00093719856 | 30 CAPSULE in 1 BOTTLE (0093-7198-56) | 30 capsule | 2002-01-30 | 0000-00-00 | No | No | Current |