fluoxetine hydrochloride
- Product NDC
- 70518-3083
- 11-digit product format
- 705183083
- Labeler code
- 70518
- Product ID
- 70518-3083_c19565ee-8747-7dc9-e053-2995a90a1993
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluoxetine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203836
- Marketing category
- ANDA
- Marketing start
- 2021-05-04
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3083-0 | 70518308300 | 30 TABLET, COATED in 1 BLISTER PACK (70518-3083-0) | 2021-05-04 | 0000-00-00 | No | No | Current |