Ondansetron
- Product NDC
- 68083-114
- 11-digit product format
- 680830114
- Labeler code
- 68083
- Product ID
- 68083-114_2f33d54b-c852-4bca-ab80-a2852c1be9b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA090648
- Marketing category
- ANDA
- Marketing start
- 2012-06-15
- 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
- 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 |
|---|
| 68083-114-01 | Ondansetron | 20 mL in 1 VIAL | INJECTION | 20 | | 8 |
| 68083-114-01 | Ondansetron | 1 in 1 CARTON | INJECTION | 1 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-114 | ONDANSETRON INJECTION [GLAND PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20220324_35716914-ac73-43c0-9aa0-09c99211d941.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-114-01 | 68083011401 | 1 VIAL in 1 CARTON (68083-114-01) / 20 mL in 1 VIAL | 1 vial | 2012-06-15 | 0000-00-00 | No | No | Current |