Fluoxetine
- Product NDC
- 55154-2638
- 11-digit product format
- 551542638
- Labeler code
- 55154
- Product ID
- 55154-2638_97385230-4710-47cf-9617-fc0f2fef78b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2024-12-04
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 310385 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-2638-0 | Fluoxetine | 10 in 1 BAG | CAPSULE | 10 | | 2 |
| 55154-2638-0 | Fluoxetine | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-2638 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [CARDINAL HEALTH 107, LLC] | 1 | Current NDC, 2 package rows | 20241207_06394c4b-99f4-4257-bf29-53c170c5a061.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55154-2638-0 | 55154263800 | 10 BLISTER PACK in 1 BAG (55154-2638-0) / 1 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2024-12-04 | No | No | Current |