Ondansetron
- Product NDC
- 0378-7734
- 11-digit product format
- 003787734
- Labeler code
- 0378
- Product ID
- 0378-7734_753fcd42-a2d1-4aa4-adf2-449643f546d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA078139
- Marketing category
- ANDA
- Marketing start
- 2007-06-25
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ondansetron | ACTIVE INGREDIENT | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| Ondansetron | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
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 |
|---|
| 0378-7734-93 | 00378773493 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-7734-93) | 2007-06-25 | 0000-00-00 | No | No | Current |
| 0378-7734-97 | 00378773497 | 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0378-7734-97) | 2007-06-25 | 0000-00-00 | No | No | Current |