Ondansetron
- Product NDC
- 63187-199
- 11-digit product format
- 631870199
- Labeler code
- 63187
- Product ID
- 63187-199_3ccb1196-6b72-478b-ba07-b05849ae83e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078152
- Marketing category
- ANDA
- Marketing start
- 2007-06-27
- Substance
- ONDANSETRON
- Active strength
- 8 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ondansetron
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ONDANSETRON | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4AF302ESOS |
| Rxcui | 104894, 312087 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-199-10 | Ondansetron | 10 in 1 BOX, UNIT-DOSE | TABLET, ORALLY DISINTEGRATING | 10 | | 11 |
| 63187-199-20 | Ondansetron | 20 in 1 BOX, UNIT-DOSE | TABLET, ORALLY DISINTEGRATING | 20 | | 11 |
| 63187-199-30 | Ondansetron | 30 in 1 BOX, UNIT-DOSE | TABLET, ORALLY DISINTEGRATING | 30 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON | ACTIVE INGREDIENT | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP] | 2 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP] | 2 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP] | 2 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-199 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240927_81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74.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 |
|---|
| 63187-199-10 | 63187019910 | 10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-10) | 2014-10-01 | 0000-00-00 | No | No | Current |
| 63187-199-20 | 63187019920 | 20 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-20) | 2025-11-11 | | No | No | Historical |
| 63187-199-30 | 63187019930 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-30) | 2025-09-25 | | No | No | Historical |