Ondansetron
- Product NDC
- 50268-647
- 11-digit product format
- 502680647
- Labeler code
- 50268
- Product ID
- 50268-647_47fb3120-1cb0-55b8-e063-6394a90a662a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA091483
- Marketing category
- ANDA
- Marketing start
- 2023-09-20
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 4 mg/5mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ondansetron
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ONDANSETRON HYDROCHLORIDE | 4 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NMH84OZK2B |
| Rxcui | 312085 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-647-11 | Ondansetron | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 2 |
| 50268-647-14 | Ondansetron | 40 in 1 TRAY | SOLUTION | 40 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-647 | ONDANSETRON SOLUTION [AVPAK] | 1 | Current NDC, 2 package rows | 20230921_05cf8d4f-ac57-4177-e063-6394a90ae804.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50268-647-11 | 50268064711 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 50268-647-14 | 50268064714 | 40 CUP, UNIT-DOSE in 1 TRAY (50268-647-14) / 5 mL in 1 CUP, UNIT-DOSE (50268-647-11) | | 2023-09-20 | No | No | Current |