Fluoxetine
- Product NDC
- 72789-557
- 11-digit product format
- 727890557
- Labeler code
- 72789
- Product ID
- 72789-557_5100b624-aa6d-8eb4-e063-6294a90a9af5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA206993
- Marketing category
- ANDA
- Marketing start
- 2021-09-08
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-557-30 | Fluoxetine | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 6 |
| 72789-557-90 | Fluoxetine | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-557-30 | 72789055730 | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-557-30) | 30 capsule | 2026-05-04 | No | No | Current |
| 72789-557-90 | 72789055790 | 90 CAPSULE in 1 BOTTLE, PLASTIC (72789-557-90) | 90 capsule | 2026-03-26 | No | No | Current |