Ondansetron
- Product NDC
- 51655-008
- 11-digit product format
- 516550008
- Labeler code
- 51655
- Product ID
- 51655-008_46dda189-a878-15b9-e063-6294a90a97d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078152
- Marketing category
- ANDA
- Marketing start
- 2022-08-08
- 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
- 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 | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4AF302ESOS |
| Rxcui | 104894 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-008-20 | Ondansetron | 20 in 1 BAG | TABLET, ORALLY DISINTEGRATING | 20 | | 2 |
| 51655-008-53 | Ondansetron | 10 in 1 BAG | TABLET, ORALLY DISINTEGRATING | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-008 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20230207_f29f5cfa-3cc4-7d53-e053-2995a90ae844.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-008-20 | 51655000820 | 20 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-008-20) | 2022-10-31 | No | No | Current |
| 51655-008-53 | 51655000853 | 10 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-008-53) | 2022-08-08 | No | No | Current |