PAROXETINE
- Product NDC
- 53217-177
- 11-digit product format
- 532170177
- Labeler code
- 53217
- Product ID
- 53217-177_fa278c8f-3315-46db-933a-1a5c6c6284ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA075356
- Marketing category
- ANDA
- Marketing start
- 2003-09-08
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 10 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53217-177-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d94b-f424-e053-dadaa90a57ce | PAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only |
| 53217-177-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d94b-f424-e053-dadaa90a57ce | PAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only |
| 53217-177-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d94b-f424-e053-dadaa90a57ce | PAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-177-30 | PAROXETINE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 53217-177-60 | PAROXETINE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 53217-177-90 | PAROXETINE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-177 | PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | Legacy NDC, 3 package rows | 20170224_b6feadfb-c2a7-4b92-89f0-e130f54ab632.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-177-30 | 53217017730 | 30 in 1 BOTTLE | Historical |
| 53217-177-60 | 53217017760 | 60 in 1 BOTTLE | Historical |
| 53217-177-90 | 53217017790 | 90 in 1 BOTTLE | Historical |