Fluoxetine
- Product NDC
- 70518-4543
- 11-digit product format
- 705184543
- Labeler code
- 70518
- Product ID
- 70518-4543_5034b0d5-da4e-965f-e063-6294a90ae8bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2026-01-07
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 310385 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4543-0 | Fluoxetine | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 2 |
| 70518-4543-1 | Fluoxetine | 50 in 1 BOX | CAPSULE | 50 | | 2 |
| 70518-4543-2 | Fluoxetine | 1 in 1 POUCH | CAPSULE | 1 | | 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 |
|---|
| 70518-4543-0 | 70518454300 | 30 CAPSULE in 1 BLISTER PACK (70518-4543-0) | 30 capsule | 2026-01-07 | No | No | Historical |
| 70518-4543-1 | 70518454301 | 50 POUCH in 1 BOX (70518-4543-1) / 1 CAPSULE in 1 POUCH (70518-4543-2) | 50 pouch | 2026-04-23 | No | No | Historical |
| 70518-4543-2 | 70518454302 | 1 in 1 POUCH | | | | | Historical |