Fluoxetine
- Product NDC
- 0615-8093
- 11-digit product format
- 006158093
- Labeler code
- 0615
- Product ID
- 0615-8093_e0e2906e-e311-4a3d-a9bd-3764f1b4cf34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA076001
- Marketing category
- ANDA
- Marketing start
- 2002-01-29
- 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
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 310384, 310385 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8093-39 | Fluoxetine | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 33 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8093 | FLUOXETINE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 15 | Current NDC, Legacy NDC, 1 package rows | 20220629_647e17f5-a15a-4e77-922c-24a5db2118bc.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 |
|---|
| 0615-8093-39 | 00615809339 | 30 CAPSULE in 1 BLISTER PACK (0615-8093-39) | 30 capsule | 2017-09-11 | 0000-00-00 | No | No | Current |