Fluoxetine
- Product NDC
- 71335-0923
- 11-digit product format
- 713350923
- Labeler code
- 71335
- Product ID
- 71335-0923_b9d5a8f5-39f1-425d-93fa-8adf95867fdb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204597
- Marketing category
- ANDA
- Marketing start
- 2015-03-16
- 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 | 310384, 310385, 313989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0923 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] | 3 | Current NDC, Legacy NDC, 9 package rows | 20190322_02283de9-6087-45f7-a9ce-3b082ce860de.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 |
|---|
| 71335-0923-1 | 71335092301 | 30 CAPSULE in 1 BOTTLE (71335-0923-1) | 30 capsule | 2018-08-09 | 0000-00-00 | No | No | Current |
| 71335-0923-2 | 71335092302 | 100 CAPSULE in 1 BOTTLE (71335-0923-2) | 100 capsule | 2018-08-09 | 0000-00-00 | No | No | Current |
| 71335-0923-3 | 71335092303 | 60 CAPSULE in 1 BOTTLE (71335-0923-3) | 60 capsule | 2018-08-09 | 0000-00-00 | No | No | Current |
| 71335-0923-4 | 71335092304 | 15 CAPSULE in 1 BOTTLE (71335-0923-4) | 15 capsule | 2018-08-09 | 0000-00-00 | No | No | Current |
| 71335-0923-5 | 71335092305 | 56 CAPSULE in 1 BOTTLE (71335-0923-5) | 56 capsule | 2018-08-09 | 0000-00-00 | No | No | Current |
| 71335-0923-6 | 71335092306 | 28 CAPSULE in 1 BOTTLE (71335-0923-6) | 28 capsule | 2018-08-09 | 0000-00-00 | No | No | Current |
| 71335-0923-7 | 71335092307 | 90 CAPSULE in 1 BOTTLE (71335-0923-7) | 90 capsule | 2018-08-09 | 0000-00-00 | No | No | Current |
| 71335-0923-8 | 71335092308 | 120 CAPSULE in 1 BOTTLE (71335-0923-8) | 120 capsule | 2018-08-09 | 0000-00-00 | No | No | Current |
| 71335-0923-9 | 71335092309 | 45 CAPSULE in 1 BOTTLE (71335-0923-9) | 45 capsule | 2018-08-09 | 0000-00-00 | No | No | Current |