Fluoxetine
- Product NDC
- 68788-7741
- 11-digit product format
- 687887741
- Labeler code
- 68788
- Product ID
- 68788-7741_d2299c69-5f4e-47f3-bffc-b6ae8312f397
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA204597
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- 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 |
|---|
| 68788-7741-1 | Fluoxetine | 100 in 1 BOTTLE | CAPSULE | 100 | | 7 |
| 68788-7741-3 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 7 |
| 68788-7741-6 | Fluoxetine | 60 in 1 BOTTLE | CAPSULE | 60 | | 7 |
| 68788-7741-9 | Fluoxetine | 90 in 1 BOTTLE | CAPSULE | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7741 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250516_ec608267-9c00-4d5c-a9ed-d89503f93d28.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 |
|---|
| 68788-7741-1 | 68788774101 | 100 CAPSULE in 1 BOTTLE (68788-7741-1) | 100 capsule | 2020-07-01 | 0000-00-00 | No | No | Current |
| 68788-7741-3 | 68788774103 | 30 CAPSULE in 1 BOTTLE (68788-7741-3) | 30 capsule | 2020-07-01 | 0000-00-00 | No | No | Current |
| 68788-7741-6 | 68788774106 | 60 CAPSULE in 1 BOTTLE (68788-7741-6) | 60 capsule | 2020-07-01 | 0000-00-00 | No | No | Current |
| 68788-7741-9 | 68788774109 | 90 CAPSULE in 1 BOTTLE (68788-7741-9) | 90 capsule | 2020-07-01 | 0000-00-00 | No | No | Current |