Fluoxetine
- Product NDC
- 0904-7345
- 11-digit product format
- 009047345
- Labeler code
- 0904
- Product ID
- 0904-7345_6cb4d9cd-a5c3-43da-a5ed-4659b864c9cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2025-01-03
- 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, 310385 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7345-61 | Fluoxetine | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 4 |
| 0904-7345-61 | Fluoxetine | 100 in 1 CARTON | CAPSULE | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7345 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MAJOR PHARMACEUTICALS] | 3 | Current NDC, 2 package rows | 20250223_76b264ce-2a13-4511-8e21-4ffad0a327f9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7345-61 | 00904734561 | 100 BLISTER PACK in 1 CARTON (0904-7345-61) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2025-01-03 | No | No | Historical |