Paroxetine
- Product NDC
- 70518-1406
- 11-digit product format
- 705181406
- Labeler code
- 70518
- Product ID
- 70518-1406_4aa4cfa5-c518-cdc1-e063-6294a90a76f4
- 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
- 2018-09-07
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Paroxetine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738483 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-1406-0 | Paroxetine | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 15 |
| 70518-1406-1 | Paroxetine | 30 in 1 BOX | TABLET, FILM COATED | 30 | | 15 |
| 70518-1406-2 | Paroxetine | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1406 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [REMEDYREPACK INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20250223_28ddc9e0-05c5-482f-9371-60bbee451b33.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-1406-0 | 70518140600 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1406-0) | | 2018-09-07 | 0000-00-00 | No | No | Current |
| 70518-1406-1 | 70518140601 | 30 POUCH in 1 BOX (70518-1406-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1406-2) | 30 pouch | 2019-12-11 | 0000-00-00 | No | No | Current |
| 70518-1406-2 | 70518140602 | 1 in 1 POUCH | | | | | | Historical |