ondansetron
- Product NDC
- 25021-777
- 11-digit product format
- 250210777
- Labeler code
- 25021
- Product ID
- 25021-777_dbbafc2b-987e-421b-bcfc-d4706859420e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA079224
- Marketing category
- ANDA
- Marketing start
- 2012-08-30
- 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 | 1740467 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-777-02 | ondansetron | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 12 |
| 25021-777-02 | ondansetron | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 12 |
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 [SAGENT PHARMACEUTICALS] | 5 | |
| ondansetron | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
| trisodium citrate dihydrate | INACTIVE INGREDIENT | B22547B95K | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-777 | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240918_ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7.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 |
|---|
| 25021-777-02 | 25021077702 | 25 VIAL in 1 CARTON (25021-777-02) / 2 mL in 1 VIAL | 25 vial | 2012-08-30 | 0000-00-00 | No | No | Current |