ondansetron
- Product NDC
- 68071-2284
- 11-digit product format
- 680712284
- Labeler code
- 68071
- Product ID
- 68071-2284_1d7831aa-71b1-6028-e063-6294a90a2354
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077557
- Marketing category
- ANDA
- Marketing start
- 2007-08-02
- 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
- 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 | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4AF302ESOS |
| Rxcui | 312087 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2284-3 | ondansetron | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 3 |
| 68071-2284-3 | ondansetron | 30 in 1 DOSE PACK | TABLET, ORALLY DISINTEGRATING | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2284 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240719_b297c163-2052-cb22-e053-2995a90a8289.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2284-3 | 68071228403 | 30 BLISTER PACK in 1 DOSE PACK (68071-2284-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 30 blister pack | 2020-10-26 | 0000-00-00 | No | No | Current |