PAROXETINE
- Product NDC
- 0904-5679
- 11-digit product format
- 009045679
- Labeler code
- 0904
- Product ID
- 0904-5679_ba1eca64-f938-4b12-b3fe-db25391774f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA075356
- Marketing category
- ANDA
- Marketing start
- 2003-09-08
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 40 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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-5679-61 | PAROXETINE | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 19 |
| 0904-5679-61 | PAROXETINE | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-5679 | PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 17 | Legacy NDC, 2 package rows | 20250213_84b1b1f0-d375-4fda-99af-9487f8ef50c7.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 |
|---|
| 0904-5679-61 | 00904567961 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5679-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2003-09-08 | 0000-00-00 | No | No | Current |