Ondansetron
- Product NDC
- 53002-1633
- 11-digit product format
- 530021633
- Labeler code
- 53002
- Product ID
- 53002-1633_43b19b12-08f6-44f4-b1a4-6bac1aa7441f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA091342
- Marketing category
- ANDA
- Marketing start
- 2011-01-27
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 4 mg/5mL
- 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 |
|---|
| 53002-1633-1 | Ondansetron | 50 mL in 1 BOTTLE, PLASTIC | SOLUTION | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1633 | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_f4bad0ab-c501-4728-b3be-9c620e8568fd.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 |
|---|
| 53002-1633-1 | 53002163301 | 50 mL in 1 BOTTLE, PLASTIC (53002-1633-1) | 50 ml | 2018-10-01 | 0000-00-00 | No | No | Current |