PAROXETINE
- Product NDC
- 12634-248
- 11-digit product format
- 126340248
- Labeler code
- 12634
- Product ID
- 12634-248_27fc49cd-e0df-014c-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA075356
- Marketing category
- ANDA
- Marketing start
- 2003-09-08
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 20 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 12634-248-01 | PAROXETINE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 12634-248-71 | PAROXETINE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-248 | PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTHECA INC.] | 2 | Legacy NDC, 2 package rows | 20151229_27fc49cd-e0de-014c-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 12634-248-01 | 12634024801 | 100 in 1 BOTTLE | Historical |
| 12634-248-71 | 12634024871 | 30 in 1 BOTTLE | Historical |