PAROXETINE
- Product NDC
- 43547-409
- 11-digit product format
- 435470409
- Labeler code
- 43547
- Product ID
- 43547-409_30b0c2b9-fb81-4015-ad28-12e658de0dea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Solco Healthcare LLC
- Application
- ANDA207188
- Marketing category
- ANDA
- Marketing start
- 2017-08-15
- Substance
- PAROXETINE MESYLATE
- Active strength
- 7.5 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PAROXETINE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE MESYLATE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M711N184JE |
| Rxcui | 1430122 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-409-03 | PAROXETINE | 30 in 1 BOTTLE | CAPSULE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-409 | PAROXETINE CAPSULE [SOLCO HEALTHCARE LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20210618_2c5836c3-2099-452e-b6af-d2d50dc359fd.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 |
|---|
| 43547-409-03 | 43547040903 | 30 CAPSULE in 1 BOTTLE (43547-409-03) | 30 capsule | 2017-08-15 | 0000-00-00 | No | No | Current |