Ondansetron
- Product NDC
- 57237-078
- 11-digit product format
- 572370078
- Labeler code
- 57237
- Product ID
- 57237-078_49380e9c-090e-44fd-b2c9-992e25e26753
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA090469
- Marketing category
- ANDA
- Marketing start
- 2010-04-12
- 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 |
|---|
| 57237-078-01 | Ondansetron | 100 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 100 | | 15 |
| 57237-078-10 | Ondansetron | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | | 15 |
| 57237-078-10 | Ondansetron | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 15 |
| 57237-078-30 | Ondansetron | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | | 15 |
| 57237-078-50 | Ondansetron | 500 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 500 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON | ACTIVE INGREDIENT | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC] | 3 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC] | 3 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-078 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RISING PHARMA HOLDINGS, INC.] | 14 | Current NDC, Legacy NDC, 5 package rows | 20240730_eb74425c-c635-4d99-8e98-e63e7359fb89.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 |
|---|
| 57237-078-01 | 57237007801 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-01) | | 2024-09-30 | | No | No | Current |
| 57237-078-10 | 57237007810 | 3 BLISTER PACK in 1 CARTON (57237-078-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2010-04-12 | 0000-00-00 | No | No | Current |
| 57237-078-30 | 57237007830 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-30) | | 2010-04-12 | 0000-00-00 | No | No | Current |
| 57237-078-50 | 57237007850 | 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-50) | | 2024-09-30 | | No | No | Current |