Fluoxetine
- Product NDC
- 0121-0721
- 11-digit product format
- 001210721
- Labeler code
- 0121
- Product ID
- 0121-0721_12f427c0-a74a-4af5-ad77-7282d4d70190
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUOXETINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA076015
- Marketing category
- ANDA
- Marketing start
- 2002-01-30
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 mg/5mL
- 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 | 20 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 310386 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-0721-04 | Fluoxetine | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0721 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 13 | Current NDC, Legacy NDC, 1 package rows | 20240328_180a07fd-1f6a-4617-b8e0-f938c65ba273.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 |
|---|
| 0121-0721-04 | 00121072104 | 120 mL in 1 BOTTLE (0121-0721-04) | 120 ml | 2002-01-30 | 0000-00-00 | No | No | Current |