Ondansetron
- Product NDC
- 53002-0590
- 11-digit product format
- 530020590
- Labeler code
- 53002
- Product ID
- 53002-0590_7942e7cf-1b46-42e7-b0c2-fbc09ae8129e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA090469
- Marketing category
- ANDA
- Marketing start
- 2010-04-12
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9bd4853-037c-6968-f4d4-9bb9a0efd1ea | Product name | 2 | 20250722 |
| 32e23bc9-ce14-4555-bb6d-bcb654d7d296 | Product name | 1 | 20201015 |
| e459f50a-1553-4aab-b6bd-1e5f0c211c49 | Product name | 1 | 20201015 |
| 909480fe-0d18-c1c1-a658-0bd9a7131822 | Product name | 5 | 20170829 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-0590-1 | Ondansetron | 3 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 3 | 5 | |
| 53002-0590-2 | Ondansetron | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | 5 | |
| 53002-0590-3 | Ondansetron | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 5 | |
| 53002-0590-4 | Ondansetron | 30 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 30 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-0590 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 4 package rows | 20230609_d11a99e2-3af2-4f6c-b0bb-1edd1ece135c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | d11a99e2-3af2-4f6c-b0bb-1edd1ece135c | 5 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | d11a99e2-3af2-4f6c-b0bb-1edd1ece135c | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53002-0590-1 | 53002059001 | 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (53002-0590-1) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-0590-2 | 53002059002 | 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (53002-0590-2) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-0590-3 | 53002059003 | 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (53002-0590-3) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-0590-4 | 53002059004 | 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (53002-0590-4) | 2017-10-01 | 0000-00-00 | No | No | Current |