Fluoxetine
- Product NDC
- 71335-1048
- 11-digit product format
- 713351048
- Labeler code
- 71335
- Product ID
- 71335-1048_09e143d4-493d-4143-b65e-e5329dca0a23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076001
- Marketing category
- ANDA
- Marketing start
- 2002-01-29
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 310384 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-1048-1 | 2024-05-17 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-2 | 2024-05-17 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-3 | 2024-05-17 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-4 | 2024-05-17 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-5 | 2024-05-17 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-6 | 2024-05-17 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-7 | 2024-05-17 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-8 | 2024-05-17 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-4 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-5 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-6 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-7 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
| 71335-1048-8 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3039-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1048 | FLUOXETINE CAPSULE [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 8 package rows | 20240518_7553d708-22a0-44ea-b907-7a86f2657f4c.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 |
|---|
| 71335-1048-1 | 71335104801 | 30 CAPSULE in 1 BOTTLE (71335-1048-1) | 30 capsule | 2019-01-25 | 0000-00-00 | No | No | Current |
| 71335-1048-2 | 71335104802 | 90 CAPSULE in 1 BOTTLE (71335-1048-2) | 90 capsule | 2018-12-31 | 0000-00-00 | No | No | Current |
| 71335-1048-3 | 71335104803 | 60 CAPSULE in 1 BOTTLE (71335-1048-3) | 60 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1048-4 | 71335104804 | 120 CAPSULE in 1 BOTTLE (71335-1048-4) | 120 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1048-5 | 71335104805 | 28 CAPSULE in 1 BOTTLE (71335-1048-5) | 28 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1048-6 | 71335104806 | 15 CAPSULE in 1 BOTTLE (71335-1048-6) | 15 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1048-7 | 71335104807 | 100 CAPSULE in 1 BOTTLE (71335-1048-7) | 100 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1048-8 | 71335104808 | 180 CAPSULE in 1 BOTTLE (71335-1048-8) | 180 capsule | 2024-05-17 | 0000-00-00 | No | No | Current |