paroxetine hydrochloride
- Product NDC
- 58517-160
- 11-digit product format
- 585170160
- Labeler code
- 58517
- Product ID
- 58517-160_113e0540-bfcd-4d68-b128-c5cfc1ce938e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- New Horizon Rx Group, LLC
- Application
- ANDA078902
- Marketing category
- ANDA
- Marketing start
- 2013-08-25
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58517-160-30 | paroxetine hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | ACTIVE INGREDIENT | X2ELS050D8 | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| PAROXETINE | ACTIVE MOIETY | 41VRH5220H | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58517-160 | PAROXETINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 2 | Legacy NDC, 1 package rows | 20131231_08ac6383-b43c-4eb6-9ca4-43b423bf9536.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 58517-160-30 | 58517016030 | 30 in 1 BOTTLE | Historical |