Fluoxetine
- Product NDC
- 84386-104
- 11-digit product format
- 843860104
- Labeler code
- 84386
- Product ID
- 84386-104_09fb3100-1e06-4cdc-8016-7e4f5d097490
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213286
- Marketing category
- ANDA
- Marketing start
- 2026-01-15
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluoxetine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOXETINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 248642, 313990 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84386-104-01 | Fluoxetine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 84386-104-30 | Fluoxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 84386-104-01 | 84386010401 | 100 TABLET, FILM COATED in 1 BOTTLE (84386-104-01) | 2026-01-15 | No | No | Current |
| 84386-104-30 | 84386010430 | 30 TABLET, FILM COATED in 1 BOTTLE (84386-104-30) | 2026-01-15 | No | No | Current |
| 84386-104-61 | 84386010461 | 6000 TABLET, FILM COATED in 1 BAG (84386-104-61) | 15-JAN-26 | | | Current |