Fluoxetine
- Product NDC
- 55111-150
- 11-digit product format
- 551110150
- Labeler code
- 55111
- Product ID
- 55111-150_ec5088cd-9e68-ba14-e274-7e3935c87f17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr.Reddy's Laboratories Limited
- Application
- ANDA076006
- Marketing category
- ANDA
- Marketing start
- 2016-09-30
- 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 | 313990 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-150-01 | Fluoxetine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 55111-150-05 | Fluoxetine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
| 55111-150-10 | Fluoxetine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
| 55111-150-30 | Fluoxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 55111-150-78 | Fluoxetine | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 9 |
| 55111-150-79 | Fluoxetine | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-150 | FLUOXETINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 9 | Current NDC, Legacy NDC, 6 package rows | 20230906_11544dea-2f5e-1536-584a-5d1f37a99770.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 |
|---|
| 55111-150-01 | 55111015001 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-150-01) | | 2016-09-30 | 0000-00-00 | No | No | Current |
| 55111-150-05 | 55111015005 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-150-05) | | 2016-09-30 | 0000-00-00 | No | No | Current |
| 55111-150-10 | 55111015010 | 1000 TABLET, FILM COATED in 1 BOTTLE (55111-150-10) | | 2016-09-30 | 0000-00-00 | No | No | Current |
| 55111-150-30 | 55111015030 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-150-30) | | 2016-09-30 | 0000-00-00 | No | No | Current |
| 55111-150-78 | 55111015078 | 10 BLISTER PACK in 1 CARTON (55111-150-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-150-79) | 10 blister pack | 2016-09-30 | 0000-00-00 | No | No | Current |
| 55111-150-79 | 55111015079 | 10 in 1 BLISTER PACK | | | | | | Historical |