Ondansetron Hydrochloride and Dextrose
- Product NDC
- 0143-9771
- 11-digit product format
- 001439771
- Labeler code
- 0143
- Product ID
- 0143-9771_b81ba160-bb0d-4d28-a191-20d2cd646bea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride and Dextrose
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- West-ward Pharmaceutical Corp
- Application
- ANDA078308
- Marketing category
- ANDA
- Marketing start
- 2009-08-04
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 32 mg/50mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9bd4853-037c-6968-f4d4-9bb9a0efd1ea | Product name | 2 | 20250722 |
| 32e23bc9-ce14-4555-bb6d-bcb654d7d296 | Product name | 1 | 20201015 |
| e459f50a-1553-4aab-b6bd-1e5f0c211c49 | Product name | 1 | 20201015 |
| 909480fe-0d18-c1c1-a658-0bd9a7131822 | Product name | 5 | 20170829 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0143-9771-06 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c9f0-621f-e053-dbdaa90a74ad | Ondansetron in Dextrose Injection |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON HYDROCHLORIDE AND DEXTROSE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON HYDROCHLORIDE AND DEXTROSE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ONDANSETRON HYDROCHLORIDE AND DEXTROSE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | ONDANSETRON HYDROCHLORIDE AND DEXTROSE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | ONDANSETRON HYDROCHLORIDE AND DEXTROSE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ONDANSETRON HYDROCHLORIDE AND DEXTROSE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 2 |