Fluoxetine
- Product NDC
- 49884-468
- 11-digit product format
- 498840468
- Labeler code
- 49884
- Product ID
- 49884-468_ea0f9b50-185b-4a12-824e-3a7628aa0906
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA209419
- Marketing category
- ANDA
- Marketing start
- 2017-11-16
- 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 |
|---|
| 49884-468-11 | Fluoxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-468 | FLUOXETINE TABLET, FILM COATED [ENDO USA, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20250112_6fff3732-efc3-4cbd-a8fa-cde3181f03e6.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 |
|---|
| 49884-468-11 | 49884046811 | 30 TABLET, FILM COATED in 1 BOTTLE (49884-468-11) | 2017-11-16 | 0000-00-00 | No | No | Current |