Fluoxetine hydrochloride
- Product NDC
- 16714-114
- 11-digit product format
- 167140114
- Labeler code
- 16714
- Product ID
- 16714-114_e90468ef-aee3-2684-3a9d-7bd58919e9de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL; ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA211721
- Marketing category
- ANDA
- Marketing start
- 2019-09-18
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 60 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 hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOXETINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 1190110 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-114-01 | Fluoxetine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-114 | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240619_1f8b1834-d5d7-72b6-d2ed-cb074344d59e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-114-01 | 16714011401 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-114-01) | 2019-09-18 | 0000-00-00 | No | No | Current |