Paroxetine
- Product NDC
- 70518-2182
- 11-digit product format
- 705182182
- Labeler code
- 70518
- Product ID
- 70518-2182_dae69454-7055-2a9b-e053-2a95a90ac30e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 30 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2182 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [REMEDYREPACK INC.] | 8 | Legacy NDC | 20250308_88b4c469-19b3-44b9-a378-c7c3f4f436db.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2182-0 | 70518218200 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2182-0) | | 2019-07-01 | 0000-00-00 | No | No | Current |
| 70518-2182-1 | 70518218201 | 30 POUCH in 1 BOX, UNIT-DOSE (70518-2182-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-2182-2) | 30 pouch | 2019-10-23 | 0000-00-00 | No | No | Current |