ONDANSETRON
- Product NDC
- 52584-069
- 11-digit product format
- 525840069
- Labeler code
- 52584
- Product ID
- 52584-069_b0da0db7-9d78-47ad-b7f2-52d9e110d12f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ONDANSETRON
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- ANDA203711
- Marketing category
- ANDA
- Marketing start
- 2018-07-03
- Marketing end
- 2023-11-30
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-069-00 | 52584006900 | 1 VIAL, SINGLE-USE in 1 BAG (52584-069-00) > 2 mL in 1 VIAL, SINGLE-USE | 2018-07-03 | 0000-00-00 | No | No | Current |