Fluoxetine
- Product NDC
- 63629-2201
- 11-digit product format
- 636292201
- Labeler code
- 63629
- Product ID
- 63629-2201_ff509ee8-400d-4128-aab8-5b389dd7f082
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209419
- Marketing category
- ANDA
- Marketing start
- 2017-11-16
- 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 |
|---|
| 63629-2201-1 | Fluoxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-2201 | FLUOXETINE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 1 package rows | 20240516_10293946-5a06-4c21-9f78-941be360b09b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-2201-1 | 63629220101 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-2201-1) | 2022-10-28 | 0000-00-00 | No | No | Current |