Paroxetine
- Product NDC
- 54458-989
- 11-digit product format
- 544580989
- Labeler code
- 54458
- Product ID
- 54458-989_3f7396e1-a66e-4ba9-bb4e-b074d72721e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- International Laboratories, LLC
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2007-12-11
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 54458-989-10 | Paroxetine | 30 in 1 BLISTER PACK | TABLET | 30 | | 41 |
| 54458-989-16 | Paroxetine | 30 in 1 BOTTLE | TABLET | 30 | | 41 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54458-989 | PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [INTERNATIONAL LABORATORIES, LLC] | 41 | Legacy NDC, 2 package rows | 20191224_49d3b871-f9fd-4d58-8405-8682c0c6e238.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 54458-989-10 | 54458098910 | 30 in 1 BLISTER PACK | Historical |
| 54458-989-16 | 54458098916 | 30 in 1 BOTTLE | Historical |