fluoxetine hydrochloride
- Product NDC
- 63629-8989
- 11-digit product format
- 636298989
- Labeler code
- 63629
- Product ID
- 63629-8989_3379faa5-91bf-90cf-e063-6394a90aa096
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluoxetine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| I9W7N6B1KJ | FLUOXETINE HYDROCHLORIDE | 56296-78-7 | FLUOXETINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-8989-1 | 63629898901 | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-8989-1) | 2021-12-07 | No | No | Historical |
| 63629-8989-2 | 63629898902 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-8989-2) | 2021-12-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| fluoxetine hydrochloride | Bryant Ranch Prepack | 2025-04-23 | HUMAN PRESCRIPTION DRUG LABEL | 101 |