ONDANSETRON
- Product NDC
- 76045-216
- 11-digit product format
- 760450216
- Labeler code
- 76045
- Product ID
- 76045-216_b71a45e3-2b90-4199-b88b-fef27cb394fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ONDANSETRON HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA202253
- Marketing category
- ANDA
- Marketing start
- 2022-05-31
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 4 mg/2mL
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| NMH84OZK2B | ONDANSETRON HYDROCHLORIDE | 103639-04-9 | ONDANSETRON HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76045-216-20 | 76045021620 | 24 BLISTER PACK in 1 CARTON (76045-216-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-216-00) / 2 mL in 1 SYRINGE, GLASS | 24 blister pack | 2022-05-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ONDANSETRON | Fresenius Kabi USA, LLC | Fresenius Kabi, USA LLC | 2023-08-16 | HUMAN PRESCRIPTION DRUG LABEL | 17 |