Ondansetron
- Product NDC
- 80425-0222
- 11-digit product format
- 804250222
- Labeler code
- 80425
- Product ID
- 80425-0222_2a9aec09-6305-2252-e063-6294a90a204a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA078152
- Marketing category
- ANDA
- Marketing start
- 2023-01-12
- 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 |
|---|
| 80425-0222-1 | Ondansetron | 30 in 1 BOX, UNIT-DOSE | TABLET, ORALLY DISINTEGRATING | 30 | | 3 |
| 80425-0222-1 | Ondansetron | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0222 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250102_f1a0ea2c-0788-4e8a-e053-2a95a90a2f32.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0222-1 | 80425022201 | 1 BOX, UNIT-DOSE in 1 CARTON (80425-0222-1) / 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE | 2023-01-12 | 0000-00-00 | No | No | Current |