Ondansetron
- Product NDC
- 17856-4091
- 11-digit product format
- 178564091
- Labeler code
- 17856
- Product ID
- 17856-4091_25fc2f67-72d9-4170-ac0c-5519cfed31bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corps
- Application
- ANDA091483
- Marketing category
- ANDA
- Marketing start
- 2010-12-17
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 4 mg/5mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-4091-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0ae0-f424-e053-dadaa90a57ce | Ondansetron Oral Solution, USP 4 MG/5 ML |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-4091-3 | Ondansetron | 5 mL in 1 CUP | SOLUTION | 5 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SACCHARIN SODIUM DIHYDRATE | INACTIVE INGREDIENT | SB8ZUX40TY | ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| STRAWBERRY | INACTIVE INGREDIENT | 4J2TY8Y81V | ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-4091 | ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | Legacy NDC, 1 package rows | 20120928_7a3c9566-1847-4867-b528-0e91fb8bab94.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312085 | ondansetron HCl 4 MG in 5 mL Oral Solution | PSN | 7a3c9566-1847-4867-b528-0e91fb8bab94 | 2 |
| 312085 | ondansetron 0.8 MG/ML Oral Solution | SCD | 7a3c9566-1847-4867-b528-0e91fb8bab94 | 2 |
| 312085 | ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution | SY | 7a3c9566-1847-4867-b528-0e91fb8bab94 | 2 |
| 312085 | ondansetron 4 MG per 5 ML Oral Solution | SY | 7a3c9566-1847-4867-b528-0e91fb8bab94 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 17856-4091-3 | 17856409103 | 5 mL in 1 CUP | 5 ml | Historical |