ONDANSETRON
- Product NDC
- 63304-346
- 11-digit product format
- 633040346
- Labeler code
- 63304
- Product ID
- 63304-346_1b169f76-a9a5-4704-a81c-094b497217a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ONDANSETRON
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Rnabaxy Pharmaceuticals Inc.
- Application
- ANDA078602
- Marketing category
- ANDA
- Marketing start
- 2012-01-10
- 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
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 63304-346-05 | ONDANSETRON | 500 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 500 | | 3 |
| 63304-346-11 | ONDANSETRON | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 3 |
| 63304-346-30 | ONDANSETRON | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | | 3 |
| 63304-346-69 | ONDANSETRON | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON | ACTIVE INGREDIENT | 4AF302ESOS | ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.] | 3 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.] | 3 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-346 | ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.] | 3 | Legacy NDC, 4 package rows | 20140116_69017f9f-1815-46d2-8e40-71cad10fa9d1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 63304-346-05 | 63304034605 | 500 in 1 BOTTLE | Historical |
| 63304-346-11 | 63304034611 | 10 in 1 BLISTER PACK | Historical |
| 63304-346-30 | 63304034630 | 30 in 1 BOTTLE | Historical |
| 63304-346-69 | 63304034669 | 1 in 1 CARTON | Historical |