Paroxetine
- Product NDC
- 0378-7001
- 11-digit product format
- 003787001
- Labeler code
- 0378
- Product ID
- 0378-7001_3e4bd491-25fa-466f-b653-f36241ffde16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA078902
- Marketing category
- ANDA
- Marketing start
- 2008-03-24
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 10 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 HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738483, 1738495, 1738503, 1738511 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7001-10 | Paroxetine | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 20 |
| 0378-7001-93 | Paroxetine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7001 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20250425_89dd7e24-85fc-4152-89ea-47ec2b48a1ed.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-7001-10 | 00378700110 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-10) | 2008-03-24 | 0000-00-00 | No | No | Current |
| 0378-7001-93 | 00378700193 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-93) | 2008-03-24 | 0000-00-00 | No | No | Current |