fluoxetine hydrochloride
- Product NDC
- 49884-335
- 11-digit product format
- 498840335
- Labeler code
- 49884
- Product ID
- 49884-335_71c75730-de24-4bfe-ad24-c92107cd5b74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluoxetine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA203836
- Marketing category
- ANDA
- Marketing start
- 2016-08-22
- 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 hydrochloride
- 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 | 248642, 313990 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-335-01 | fluoxetine hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | | 20 |
| 49884-335-10 | fluoxetine hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET, COATED | 1000 | | 20 |
| 49884-335-11 | fluoxetine hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | | 20 |
| 49884-335-82 | fluoxetine hydrochloride | 2000 in 1 BOTTLE, PLASTIC | TABLET, COATED | 2000 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-335 | FLUOXETINE HYDROCHLORIDE TABLET, COATED [ENDO USA, INC.] | 20 | Current NDC, Legacy NDC, 4 package rows | 20250109_53ac797d-8792-4a8c-9708-d1de3d377e8f.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 |
|---|
| 49884-335-01 | 49884033501 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-01) | 2016-08-22 | 0000-00-00 | No | No | Current |
| 49884-335-10 | 49884033510 | 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-10) | 2016-08-22 | 0000-00-00 | No | No | Current |
| 49884-335-11 | 49884033511 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-11) | 2016-08-22 | 0000-00-00 | No | No | Current |
| 49884-335-82 | 49884033582 | 2000 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-82) | 2016-08-22 | 0000-00-00 | No | No | Current |