Ondansetron
- Product NDC
- 55150-126
- 11-digit product format
- 551500126
- Labeler code
- 55150
- Product ID
- 55150-126_344b6a95-a41f-4ef0-8434-623257a5f9c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA202599
- Marketing category
- ANDA
- Marketing start
- 2012-12-21
- 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, 1740467 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-126-20 | Ondansetron | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 11 |
| 55150-126-20 | Ondansetron | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 11 |
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 [AUROMEDICS PHARMA LLC] | 6 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 6 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 6 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 6 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-126 | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [EUGIA US LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240120_1cc94c7a-617c-4238-8248-e3fabc9612c7.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 |
|---|
| 55150-126-20 | 55150012620 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-126-20) / 20 mL in 1 VIAL, MULTI-DOSE | 2012-12-21 | 0000-00-00 | No | No | Current |