Fluoxetine
- Product NDC
- 25000-147
- 11-digit product format
- 250000147
- Labeler code
- 25000
- Product ID
- 25000-147_46219345-2dd8-4502-a0fc-1631e354dc98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA075465
- Marketing category
- ANDA
- Marketing start
- 2022-01-29
- 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, 313989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-147-03 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 6 |
| 25000-147-08 | Fluoxetine | 100 in 1 BOTTLE | CAPSULE | 100 | | 6 |
| 25000-147-14 | Fluoxetine | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25000-147 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MARKSANS PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 3 package rows | 20230927_8e822937-9431-446f-88c4-330a25d12439.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 |
|---|
| 25000-147-03 | 25000014703 | 30 CAPSULE in 1 BOTTLE (25000-147-03) | 30 capsule | 2022-01-29 | 0000-00-00 | No | No | Current |
| 25000-147-08 | 25000014708 | 100 CAPSULE in 1 BOTTLE (25000-147-08) | 100 capsule | 2022-01-29 | 0000-00-00 | No | No | Current |
| 25000-147-14 | 25000014714 | 1000 CAPSULE in 1 BOTTLE (25000-147-14) | 1000 capsule | 2022-02-19 | 0000-00-00 | No | No | Current |