Fluoxetine
- Product NDC
- 59651-324
- 11-digit product format
- 596510324
- Labeler code
- 59651
- Product ID
- 59651-324_5f402504-f531-4cbf-95d5-fe23b90630b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- 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 |
|---|
| 59651-324-30 | Fluoxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-324 | FLUOXETINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240126_5336ce59-7a6c-4db9-8512-299cc5e599c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59651-324-30 | 59651032430 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-324-30) | 2020-06-10 | 0000-00-00 | No | No | Current |