ondansetron hydrochloride
- Product NDC
- 83270-161
- 11-digit product format
- 832700161
- Labeler code
- 83270
- Product ID
- 83270-161_438c722e-25b2-ae3f-e063-6294a90a3af8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Onesource Specialty Pharma Limited
- Application
- ANDA078257
- 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 | 283504 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83270-161-01 | ondansetron hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 83270-161-01 | ondansetron hydrochloride | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION | 20 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83270-161-01 | 83270016101 | 1 VIAL, MULTI-DOSE in 1 CARTON (83270-161-01) / 20 mL in 1 VIAL, MULTI-DOSE | 2023-09-30 | No | No | Current |