Paroxetine
- Product NDC
- 13107-157
- 11-digit product format
- 131070157
- Labeler code
- 13107
- Product ID
- 13107-157_c399d3cd-13a5-4493-9a93-c4bf5e2532fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurolife Pharma LLC
- Application
- ANDA078406
- Marketing category
- ANDA
- Marketing start
- 2009-12-03
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- 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
- Paroxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 40 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 |
|---|
| 13107-157-01 | Paroxetine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 15 |
| 13107-157-05 | Paroxetine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 15 |
| 13107-157-30 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 15 |
| 13107-157-90 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 15 |
| 13107-157-99 | Paroxetine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | ACTIVE INGREDIENT | X2ELS050D8 | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| PAROXETINE | ACTIVE MOIETY | 41VRH5220H | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-157 | PAROXETINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] | 14 | Current NDC, Legacy NDC, 5 package rows | 20250131_e1ea4019-bb66-403c-a3d5-6ae056a59116.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 |
|---|
| 13107-157-01 | 13107015701 | 100 TABLET, FILM COATED in 1 BOTTLE (13107-157-01) | 2009-12-03 | 0000-00-00 | No | No | Current |
| 13107-157-05 | 13107015705 | 500 TABLET, FILM COATED in 1 BOTTLE (13107-157-05) | 2009-12-03 | 0000-00-00 | No | No | Current |
| 13107-157-30 | 13107015730 | 30 TABLET, FILM COATED in 1 BOTTLE (13107-157-30) | 2009-12-03 | 0000-00-00 | No | No | Current |
| 13107-157-90 | 13107015790 | 90 TABLET, FILM COATED in 1 BOTTLE (13107-157-90) | 2009-12-03 | 0000-00-00 | No | No | Current |
| 13107-157-99 | 13107015799 | 1000 TABLET, FILM COATED in 1 BOTTLE (13107-157-99) | 2009-12-03 | 0000-00-00 | No | No | Current |