Ondansetron
- Product NDC
- 55045-3848
- 11-digit product format
- 550453848
- Labeler code
- 55045
- Product ID
- 55045-3848_96dae489-ae80-4953-8d9a-df682794cbdf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA078152
- Marketing category
- ANDA
- Marketing start
- 2007-06-27
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON
- Active strength
- 4 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 55045-3848-9 | Ondansetron | 30 in 1 BOX, UNIT-DOSE | TABLET, ORALLY DISINTEGRATING | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON | ACTIVE INGREDIENT | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [DISPENSING SOLUTIONS, INC.] | 1 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [DISPENSING SOLUTIONS, INC.] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [DISPENSING SOLUTIONS, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ONDANSETRON TABLET, ORALLY DISINTEGRATING [DISPENSING SOLUTIONS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [DISPENSING SOLUTIONS, INC.] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ONDANSETRON TABLET, ORALLY DISINTEGRATING [DISPENSING SOLUTIONS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [DISPENSING SOLUTIONS, INC.] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | ONDANSETRON TABLET, ORALLY DISINTEGRATING [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55045-3848 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 1 package rows | 20111007_e5e8353f-4e4c-4036-9376-2ac205d13b14.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 55045-3848-9 | 55045384809 | 30 in 1 BOX, UNIT-DOSE | Historical |