Ondansetron Hydrochloride
- Product NDC
- 85509-1057
- 11-digit product format
- 855091057
- Labeler code
- 85509
- Product ID
- 85509-1057_4010608d-027c-0467-e063-6294a90a63e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PHOENIX RX LLC
- Application
- ANDA078539
- Marketing category
- ANDA
- Marketing start
- 2007-07-31
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 4 mg/1
- 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 | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NMH84OZK2B |
| Rxcui | 198052 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85509-1057-4 | Ondansetron Hydrochloride | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85509-1057-4 | 85509105704 | 12 TABLET, FILM COATED in 1 BOTTLE (85509-1057-4) | 2025-07-31 | No | No | Current |