PAROXETINE
- Product NDC
- 70518-1460
- 11-digit product format
- 705181460
- Labeler code
- 70518
- Product ID
- 70518-1460_4900bb35-ed0a-8189-e063-6294a90a9c82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075356
- Marketing category
- ANDA
- Marketing start
- 2018-10-04
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 30 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 ANHYDROUS | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3I3T11UD2S |
| Rxcui | 1738503 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-1460-0 | PAROXETINE | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 18 |
| 70518-1460-1 | PAROXETINE | 100 in 1 BOX | TABLET, FILM COATED | 100 | | 18 |
| 70518-1460-2 | PAROXETINE | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1460 | PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.] | 15 | Current NDC, Legacy NDC, 3 package rows | 20250429_8e176ff2-ed3a-4909-94e1-6b9a3581a621.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 |
|---|
| 70518-1460-0 | 70518146000 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1460-0) | | 2018-10-04 | 0000-00-00 | No | No | Current |
| 70518-1460-1 | 70518146001 | 100 POUCH in 1 BOX (70518-1460-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1460-2) | 100 pouch | 2020-11-09 | 0000-00-00 | No | No | Current |
| 70518-1460-2 | 70518146002 | 1 in 1 POUCH | | | | | | Historical |