Ondansetron
- Product NDC
- 68071-3611
- 11-digit product format
- 680713611
- Labeler code
- 68071
- Product ID
- 68071-3611_1b406836-6662-90fd-e063-6294a90aaea0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA078776
- Marketing category
- ANDA
- Marketing start
- 2007-11-28
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ondansetron
- Listing expiration
- 2026-12-31
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 |
|---|
| 68071-3611-5 | Ondansetron | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 68071-3611-5 | Ondansetron | 50 mL in 1 BOTTLE, PLASTIC | SOLUTION | 50 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3611 | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 2 package rows | 20240620_1b406d22-f1bf-460d-e063-6294a90a6b6f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3611-5 | 68071361105 | 1 BOTTLE, PLASTIC in 1 CARTON (68071-3611-5) / 50 mL in 1 BOTTLE, PLASTIC | 2024-06-19 | No | No | Historical |