ZELAPAR
- Product NDC
- 0187-0453
- 11-digit product format
- 001870453
- Labeler code
- 0187
- Product ID
- 0187-0453_f8d8f532-d8a6-4eff-baab-325fed820cdb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SELEGILINE HYDROCHLORIDE
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Bausch Health US, LLC
- Application
- NDA021479
- Marketing category
- NDA
- Marketing start
- 2006-06-14
- Substance
- SELEGILINE HYDROCHLORIDE
- Active strength
- 1.25 mg/1
- Pharmacologic classes
- Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B 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
- ZELAPAR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SELEGILINE HYDROCHLORIDE | 1.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6W731X367Q |
| Rxcui | 859190, 859192 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0187-0453-02 | ZELAPAR | 10 in 1 POUCH | TABLET, ORALLY DISINTEGRATING | 10 | | 12 |
| 0187-0453-02 | ZELAPAR | 6 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 6 | | 12 |
| 0187-0453-03 | ZELAPAR | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | | 12 |
| 0187-0453-03 | ZELAPAR | 10 in 1 POUCH | TABLET, ORALLY DISINTEGRATING | 10 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SELEGILINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6W731X367Q | ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 3 | |
| SELEGILINE | ACTIVE MOIETY | 2K1V7GP655 | ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 3 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 3 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0187-0453 | ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [BAUSCH HEALTH US, LLC] | 12 | Current NDC, Legacy NDC, 4 package rows | 20210831_380d7717-2a79-42f3-a712-efe5e7696ba0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0187-0453-02 | 00187045302 | 6 POUCH in 1 CARTON (0187-0453-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH | 6 pouch | 2006-06-14 | 0000-00-00 | No | No | Current |
| 0187-0453-03 | 00187045303 | 1 in 1 CARTON | | | | | | Historical |