Ondansetron Hydrochloride
- Product NDC
- 51655-813
- 11-digit product format
- 516550813
- Labeler code
- 51655
- Product ID
- 51655-813_4bbb7666-8259-6d09-e063-6394a90a08e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078539
- Marketing category
- ANDA
- Marketing start
- 2021-06-10
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ondansetron Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ONDANSETRON HYDROCHLORIDE | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NMH84OZK2B |
| Rxcui | 312086 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-813-54 | Ondansetron Hydrochloride | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-813 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 1 package rows | 20241225_db99c77a-0b01-9da6-e053-2a95a90a5199.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-813-54 | 51655081354 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-813-54) | 2021-06-10 | No | No | Current |