ondansetron hydrochloride
- Product NDC
- 83270-160
- 11-digit product format
- 832700160
- Labeler code
- 83270
- Product ID
- 83270-160_438c3d28-8bee-50f0-e063-6394a90a18e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Onesource Specialty Pharma Limited
- Application
- ANDA078244
- Marketing category
- ANDA
- Marketing start
- 2023-09-30
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ondansetron hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ONDANSETRON HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NMH84OZK2B |
| Rxcui | 1740467 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83270-160-03 | ondansetron hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 1 |
| 83270-160-03 | ondansetron hydrochloride | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83270-160-03 | 83270016003 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83270-160-03) / 2 mL in 1 VIAL, SINGLE-DOSE | 2023-09-30 | No | No | Historical |