Fluoxetine
- Product NDC
- 71335-2597
- 11-digit product format
- 713352597
- Labeler code
- 71335
- Product ID
- 71335-2597_40272603-bcda-461e-b7a8-dcce9398c268
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213265
- Marketing category
- ANDA
- Marketing start
- 2020-06-10
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 60 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 | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 1190110 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2597-1 | Fluoxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 100 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2597 | FLUOXETINE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 100 | Current NDC, 1 package rows | 20250214_7a631271-9597-42a4-a924-1d06ecaba8c8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2597-1 | 71335259701 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2597-1) | 2025-02-12 | No | No | Current |