Fluoxetine
- Product NDC
- 68001-672
- 11-digit product format
- 680010672
- Labeler code
- 68001
- Product ID
- 68001-672_4ddbd2ee-0572-129c-e063-6394a90a2fbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2026-01-08
- 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 | 310384, 310385, 313989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68001-672-00 | Fluoxetine | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 68001-672-03 | Fluoxetine | 500 in 1 BOTTLE | CAPSULE | 500 | | 2 |
| 68001-672-04 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-672-00 | 68001067200 | 100 CAPSULE in 1 BOTTLE (68001-672-00) | 100 capsule | 2026-01-08 | No | No | Historical |
| 68001-672-03 | 68001067203 | 500 CAPSULE in 1 BOTTLE (68001-672-03) | 500 capsule | 2026-01-08 | No | No | Historical |
| 68001-672-04 | 68001067204 | 30 CAPSULE in 1 BOTTLE (68001-672-04) | 30 capsule | 2026-02-20 | No | No | Historical |