Fluoxetine
- Product NDC
- 68071-2275
- 11-digit product format
- 680712275
- Labeler code
- 68071
- Product ID
- 68071-2275_1d77e6db-8604-5308-e063-6394a90a514d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA204597
- Marketing category
- ANDA
- Marketing start
- 2015-03-16
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2275-3 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2275 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240719_b1409772-e719-67f5-e053-2995a90ab5b6.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 |
|---|
| 68071-2275-3 | 68071227503 | 30 CAPSULE in 1 BOTTLE (68071-2275-3) | 30 capsule | 2020-10-09 | 0000-00-00 | No | No | Current |