Ondansetron
- Product NDC
- 0409-4755
- 11-digit product format
- 004094755
- Labeler code
- 0409
- Product ID
- 0409-4755_aeec44c2-fd88-48cc-ad91-599688f5319f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ONDANSETRON
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA077548
- Marketing category
- ANDA
- Marketing start
- 2008-10-16
- 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
- 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 | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NMH84OZK2B |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-4755-03 | Ondansetron | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 34 |
| 0409-4755-18 | Ondansetron | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 34 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-4755 | ONDANSETRON INJECTION, SOLUTION [HOSPIRA, INC.] | 32 | Current NDC, Legacy NDC, 2 package rows | 20250109_6a11f61b-2318-4382-2b91-4366e4bb53fa.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 |
|---|
| 0409-4755-03 | 00409475503 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4755-03) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-4755-18) | | 2008-10-16 | 0000-00-00 | No | No | Current |
| 0409-4755-18 | 00409475518 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |