PAXIL
- Product NDC
- 60505-4520
- 11-digit product format
- 605054520
- Labeler code
- 60505
- Product ID
- 60505-4520_62b4ffe1-48e2-6dd5-d7ca-28e8efe36686
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp
- Application
- NDA020031
- Marketing category
- NDA
- Marketing start
- 2019-03-11
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PAXIL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 207349, 207350, 211699, 211700, 1738483, 1738495, 1738503, 1738511 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-4520-3 | PAXIL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-4520 | PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP] | 10 | Current NDC, Legacy NDC, 1 package rows | 20240912_ef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e.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 |
|---|
| 60505-4520-3 | 60505452003 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4520-3) | 2019-03-11 | 0000-00-00 | No | No | Current |