Ondansetron
- Product NDC
- 68788-8666
- 11-digit product format
- 687888666
- Labeler code
- 68788
- Product ID
- 68788-8666_4b9f6e3e-3652-4425-af52-6a99a34087cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078152
- Marketing category
- ANDA
- Marketing start
- 2024-05-14
- 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 |
|---|
| 68788-8666-1 | Ondansetron | 30 in 1 PACKET | TABLET, ORALLY DISINTEGRATING | 30 | | 2 |
| 68788-8666-3 | Ondansetron | 10 in 1 BOX, UNIT-DOSE | TABLET, ORALLY DISINTEGRATING | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8666 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20240531_7975d78c-9bb6-467a-9c2d-ea15bde7af5c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8666-1 | 68788866601 | 30 TABLET, ORALLY DISINTEGRATING in 1 PACKET (68788-8666-1) | 2024-05-14 | No | No | Historical |
| 68788-8666-3 | 68788866603 | 10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68788-8666-3) | 2024-05-14 | No | No | Historical |