ondansetron
- Product NDC
- 53002-0600
- 11-digit product format
- 530020600
- Labeler code
- 53002
- Product ID
- 53002-0600_5f3aa8c9-1704-42ab-ac93-4684c6a84446
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077851
- Marketing category
- ANDA
- Marketing start
- 2007-06-25
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON HYDROCHLORIDE
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-0600-1 | ondansetron | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | | 5 |
| 53002-0600-2 | ondansetron | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 5 |
| 53002-0600-3 | ondansetron | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 5 |
| 53002-0600-4 | ondansetron | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-0600 | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 4 package rows | 20230609_079fdfb4-8007-4f5a-a8fa-4b72c3748632.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 |
|---|
| 53002-0600-1 | 53002060001 | 3 TABLET, FILM COATED in 1 BOTTLE (53002-0600-1) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-0600-2 | 53002060002 | 6 TABLET, FILM COATED in 1 BOTTLE (53002-0600-2) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-0600-3 | 53002060003 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-0600-3) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-0600-4 | 53002060004 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-0600-4) | 2017-10-01 | 0000-00-00 | No | No | Current |