Ondansetron
- Product NDC
- 0409-4759
- 11-digit product format
- 004094759
- Labeler code
- 0409
- Product ID
- 0409-4759_aeec44c2-fd88-48cc-ad91-599688f5319f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ONDANSETRON
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA077473
- Marketing category
- ANDA
- Marketing start
- 2006-11-07
- 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 |
|---|
| 0409-4759-01 | Ondansetron | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 34 |
| 0409-4759-01 | Ondansetron | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 34 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-4759 | 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0409-4759-01 | 00409475901 | 1 VIAL, MULTI-DOSE in 1 CARTON (0409-4759-01) / 20 mL in 1 VIAL, MULTI-DOSE | 2006-11-07 | 0000-00-00 | No | No | Current |