Fluoxetine
- Product NDC
- 0615-8612
- 11-digit product format
- 006158612
- Labeler code
- 0615
- Product ID
- 0615-8612_e6352f3d-7ecb-4aa5-8192-176316a63786
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2025-07-11
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 313989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8612-05 | Fluoxetine | 15 in 1 BLISTER PACK | CAPSULE | 15 | | 1 |
| 0615-8612-39 | Fluoxetine | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8612-05 | 00615861205 | 15 CAPSULE in 1 BLISTER PACK (0615-8612-05) | 15 capsule | 2026-04-07 | No | No | Historical |
| 0615-8612-39 | 00615861239 | 30 CAPSULE in 1 BLISTER PACK (0615-8612-39) | 30 capsule | 2026-04-07 | No | No | Historical |