Fluoxetine HCl
- Product NDC
- 52427-576
- 11-digit product format
- 524270576
- Labeler code
- 52427
- Product ID
- 52427-576_9b1ed575-955c-8539-2930-0a5920fcb775
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Almatica Pharma Inc.
- Application
- NDA202133
- Marketing category
- NDA
- Marketing start
- 2017-09-01
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52427-576 | FLUOXETINE HCL TABLET, FILM COATED [ALMATICA PHARMA INC.] | 10 | Legacy NDC | 20240502_b47b291f-3340-0c2a-3585-0926b9c1a71f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52427-576-30 | 52427057630 | 30 TABLET, FILM COATED in 1 BOTTLE (52427-576-30) | 2017-09-01 | 0000-00-00 | No | No | Current |