Fluoxetine
- Product NDC
- 54838-523
- 11-digit product format
- 548380523
- Labeler code
- 54838
- Product ID
- 54838-523_bda5665d-4bcd-4426-9397-e438485d0d29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA077849
- Marketing category
- ANDA
- Marketing start
- 2009-08-27
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 mg/5mL
- 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 | 20 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 310386 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54838-523-40 | Fluoxetine | 120 mL in 1 BOTTLE, PLASTIC | LIQUID | 120 | | 39 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54838-523 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [LANNETT COMPANY, INC.] | 39 | Current NDC, Legacy NDC, 1 package rows | 20230831_c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1.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 |
|---|
| 54838-523-40 | 54838052340 | 120 mL in 1 BOTTLE, PLASTIC (54838-523-40) | 120 ml | 2009-08-27 | 0000-00-00 | No | No | Current |