Ondansetron
- Product NDC
- 62135-878
- 11-digit product format
- 621350878
- Labeler code
- 62135
- Product ID
- 62135-878_1ba47f65-782d-bcae-e063-6294a90a39a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA077406
- Marketing category
- ANDA
- Marketing start
- 2006-12-26
- Substance
- ONDANSETRON
- Active strength
- 16 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 | 16 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4AF302ESOS |
| Rxcui | 104894, 312087, 2685489, 2685613 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-878-30 | Ondansetron | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-878 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [CHARTWELL RX, LLC] | 4 | Current NDC, 1 package rows | 20240628_4c74336c-11ec-420a-80e1-d8e4a8f1c46d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-878-30 | 62135087830 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-878-30) | 2024-06-20 | No | No | Historical |