paroxetine hydrochloride
- Product NDC
- 69584-674
- 11-digit product format
- 695840674
- Labeler code
- 69584
- Product ID
- 69584-674_2ac7f06f-af78-4705-a209-d9041b2de825
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Oxford Pharmaceuticals, LLC
- Application
- ANDA076968
- Marketing category
- ANDA
- Marketing start
- 2022-11-14
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- paroxetine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738483, 1738495, 1738503, 1738511 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69584-674-03 | paroxetine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 69584-674-09 | paroxetine hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
| 69584-674-10 | paroxetine hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 69584-674-50 | paroxetine hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 69584-674-90 | paroxetine hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69584-674 | PAROXETINE HYDROCHLORIDE TABLET, FILM COATED [OXFORD PHARMACEUTICALS, LLC] | 2 | Current NDC, Legacy NDC, 5 package rows | 20240814_25182b68-8f7a-48e8-9788-6818b0984b29.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69584-674-03 | 69584067403 | 30 TABLET, FILM COATED in 1 BOTTLE (69584-674-03) | 2022-11-14 | 0000-00-00 | No | No | Current |
| 69584-674-09 | 69584067409 | 90 TABLET, FILM COATED in 1 BOTTLE (69584-674-09) | 2022-11-14 | 0000-00-00 | No | No | Current |
| 69584-674-10 | 69584067410 | 100 TABLET, FILM COATED in 1 BOTTLE (69584-674-10) | 2022-11-14 | 0000-00-00 | No | No | Current |
| 69584-674-50 | 69584067450 | 500 TABLET, FILM COATED in 1 BOTTLE (69584-674-50) | 2022-11-14 | 0000-00-00 | No | No | Current |
| 69584-674-90 | 69584067490 | 1000 TABLET, FILM COATED in 1 BOTTLE (69584-674-90) | 2022-11-14 | 0000-00-00 | No | No | Current |