fluoxetine
- Product NDC
- 75834-148
- 11-digit product format
- 758340148
- Labeler code
- 75834
- Product ID
- 75834-148_3ca13da1-2f1e-5165-e063-6394a90a17fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluoxetine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NIVAGEN PHARMACEUTICALS, INC.
- Application
- ANDA209695
- Marketing category
- ANDA
- Marketing start
- 2017-12-11
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 60 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 | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 1190110 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-148-30 | fluoxetine | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-148 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET [NIVAGEN PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250109_f4cbf9a9-1d7f-4aa0-a18d-fba50d49bd2b.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 |
|---|
| 75834-148-30 | 75834014830 | 30 TABLET in 1 BOTTLE (75834-148-30) | 30 tablet | 2017-12-11 | 0000-00-00 | No | No | Current |