Fluoxetine
- Product NDC
- 33261-045
- 11-digit product format
- 332610045
- Labeler code
- 33261
- Product ID
- 33261-045_ca0dc511-15a7-4911-a012-ad975bfc34d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2008-01-31
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 33261-045-28 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f20f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987 |
| 33261-045-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f20f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987 |
| 33261-045-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f20f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987 |
| 33261-045-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f20f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33261-045-28 | Fluoxetine | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 1 |
| 33261-045-30 | Fluoxetine | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 1 |
| 33261-045-60 | Fluoxetine | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 1 |
| 33261-045-90 | Fluoxetine | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-045 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 4 package rows | 20140321_39c95b74-bdae-4e2f-82a0-8546d7f394c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-045-28 | 33261004528 | 28 in 1 BOTTLE, PLASTIC | Historical |
| 33261-045-30 | 33261004530 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 33261-045-60 | 33261004560 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 33261-045-90 | 33261004590 | 90 in 1 BOTTLE, PLASTIC | Historical |