Fluoxetine
- Product NDC
- 42708-182
- 11-digit product format
- 427080182
- Labeler code
- 42708
- Product ID
- 42708-182_45872a42-3b7c-bddd-e063-6294a90ae0d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- QPharma Inc
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2008-01-31
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 310385 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42708-182-30 | Fluoxetine | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42708-182 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [QPHARMA INC] | 2 | Current NDC, 1 package rows | 20240515_fc754dff-cecb-fc6b-e053-6394a90ab371.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 |
|---|
| 42708-182-30 | 42708018230 | 30 CAPSULE in 1 BOTTLE, PLASTIC (42708-182-30) | 30 capsule | 2023-05-26 | Yes | No | Current |