FLUOXETINE HCL
- Product NDC
- 64380-900
- 11-digit product format
- 643800900
- Labeler code
- 64380
- Product ID
- 64380-900_adcbffe8-9a0c-421a-9a18-21faac0207eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluoxetine hcl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA212683
- Marketing category
- ANDA
- Marketing start
- 2024-11-08
- Substance
- FLUOXETINE
- Active strength
- 60 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 HCL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOXETINE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 01K63SUP8D |
| Rxcui | 1190110 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-900-04 | FLUOXETINE HCL | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-900 | FLUOXETINE HCL TABLET [STRIDES PHARMA SCIENCE LIMITED] | 3 | Current NDC, 1 package rows | 20241109_d09a5026-b3eb-403f-bf31-d5991a81a8ce.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 |
|---|
| 64380-900-04 | 64380090004 | 30 TABLET in 1 BOTTLE (64380-900-04) | 30 tablet | 2024-11-08 | No | No | Historical |