Fluoxetine
- Product NDC
- 71209-042
- 11-digit product format
- 712090042
- Labeler code
- 71209
- Product ID
- 71209-042_1922c101-5662-4952-9ac2-6470bbfd5ad3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Cadila Pharmaceuticals Limited
- Application
- ANDA206993
- Marketing category
- ANDA
- Marketing start
- 2022-12-15
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 310384, 310385, 313989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71209-042-01 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 11 |
| 71209-042-05 | Fluoxetine | 100 in 1 BOTTLE | CAPSULE | 100 | | 11 |
| 71209-042-10 | Fluoxetine | 500 in 1 BOTTLE | CAPSULE | 500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71209-042 | FLUOXETINE CAPSULE [CADILA PHARMACEUTICALS LIMITED] | 11 | Current NDC, Legacy NDC, 3 package rows | 20240717_9651816f-58f5-4bf8-8183-6f3d84d36b5c.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 |
|---|
| 71209-042-01 | 71209004201 | 30 CAPSULE in 1 BOTTLE (71209-042-01) | 30 capsule | 2022-12-15 | 0000-00-00 | No | No | Current |
| 71209-042-05 | 71209004205 | 100 CAPSULE in 1 BOTTLE (71209-042-05) | 100 capsule | 2022-12-15 | 0000-00-00 | No | No | Current |
| 71209-042-10 | 71209004210 | 500 CAPSULE in 1 BOTTLE (71209-042-10) | 500 capsule | 2022-12-15 | 0000-00-00 | No | No | Current |