Fluoxetine
- Product NDC
- 71205-188
- 11-digit product format
- 712050188
- Labeler code
- 71205
- Product ID
- 71205-188_9c7dbd85-1235-4b6f-98df-deec21ca815b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA075452
- Marketing category
- ANDA
- Marketing start
- 2002-01-30
- 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
- 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 | 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 |
|---|
| 71205-188-30 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 4 |
| 71205-188-60 | Fluoxetine | 60 in 1 BOTTLE | CAPSULE | 60 | | 4 |
| 71205-188-90 | Fluoxetine | 90 in 1 BOTTLE | CAPSULE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-188 | FLUOXETINE CAPSULE [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 3 package rows | 20241024_5ebf287e-fc95-4a2c-a496-62c7cf6cbf38.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 |
|---|
| 71205-188-30 | 71205018830 | 30 CAPSULE in 1 BOTTLE (71205-188-30) | 30 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 71205-188-60 | 71205018860 | 60 CAPSULE in 1 BOTTLE (71205-188-60) | 60 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 71205-188-90 | 71205018890 | 90 CAPSULE in 1 BOTTLE (71205-188-90) | 90 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |