Fluoxetine
- Product NDC
- 68645-131
- 11-digit product format
- 686450131
- Labeler code
- 68645
- Product ID
- 68645-131_4c222d2c-813c-5520-e063-6294a90affe6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA076001
- Marketing category
- ANDA
- Marketing start
- 2011-01-25
- 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
- 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 | 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 |
|---|
| 68645-131-54 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-131 | FLUOXETINE CAPSULE [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 15 | Current NDC, Legacy NDC, 1 package rows | 20250321_b07f9eab-44ac-4667-bd46-52d736daa5d6.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 |
|---|
| 68645-131-54 | 68645013154 | 30 CAPSULE in 1 BOTTLE (68645-131-54) | 30 capsule | 2011-01-25 | 0000-00-00 | No | No | Current |