ONDANSETRON
- Product NDC
- 67184-0507
- 11-digit product format
- 671840507
- Labeler code
- 67184
- Product ID
- 67184-0507_cd294344-e9fc-4b11-811f-0a8843db3227
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ONDANSETRON
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA203711
- Marketing category
- ANDA
- Marketing start
- 2014-09-08
- 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 |
|---|
| 67184-0507-5 | ONDANSETRON | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 9 |
| 67184-0507-5 | ONDANSETRON | 2 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 2 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 6 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ONDANSETRON INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 6 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | ONDANSETRON INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 6 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | ONDANSETRON INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ONDANSETRON INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0507 | ONDANSETRON INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20220303_5e09e262-dadf-4ae0-825e-448ea8dac174.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 |
|---|
| 67184-0507-5 | 67184050705 | 5 VIAL, SINGLE-USE in 1 CARTON (67184-0507-5) / 2 mL in 1 VIAL, SINGLE-USE | 2014-09-08 | 0000-00-00 | No | No | Current |