Paroxetine
- Product NDC
- 63187-927
- 11-digit product format
- 631870927
- Labeler code
- 63187
- Product ID
- 63187-927_b4618a70-5719-43c4-9010-ef790f7495cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Paroxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738495 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-927-30 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 63187-927-60 | Paroxetine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
| 63187-927-90 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-927 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 3 package rows | 20220512_8526c68d-221c-4822-9532-1d7868cff35e.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 |
|---|
| 63187-927-30 | 63187092730 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-927-30) | 2017-11-01 | 0000-00-00 | No | No | Current |
| 63187-927-60 | 63187092760 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-927-60) | 2017-11-01 | 0000-00-00 | No | No | Current |
| 63187-927-90 | 63187092790 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-927-90) | 2017-11-01 | 0000-00-00 | No | No | Current |