Fluoxetine Hydrochloride
- Product NDC
- 70954-600
- 11-digit product format
- 709540600
- Labeler code
- 70954
- Product ID
- 70954-600_0f4f464b-d8a7-400c-ab63-f0510ba8b982
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA216448
- Marketing category
- ANDA
- Marketing start
- 2022-11-09
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluoxetine Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 70954-600-10 | Fluoxetine Hydrochloride | 120 mL in 1 BOTTLE, PLASTIC | SOLUTION | 120 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-600 | FLUOXETINE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240921_1ffe57c3-6f70-4075-aacb-d87a3990fdea.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 |
|---|
| 70954-600-10 | 70954060010 | 120 mL in 1 BOTTLE, PLASTIC (70954-600-10) | 120 ml | 2022-11-09 | 0000-00-00 | No | No | Current |