Ondansetron
- Product NDC
- 43063-770
- 11-digit product format
- 430630770
- Labeler code
- 43063
- Product ID
- 43063-770_48d46d34-3176-1749-e063-6394a90a9a42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077535
- Marketing category
- ANDA
- Marketing start
- 2007-06-25
- 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
- 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 |
|---|
| 43063-770-06 | Ondansetron | 6 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 6 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-770 | ONDANSETRON TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 21 | Current NDC, Legacy NDC, 1 package rows | 20241016_15d0a711-ef3b-4d93-8fbc-17a45f96af8a.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 |
|---|
| 43063-770-06 | 43063077006 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-770-06) | 2014-03-03 | 0000-00-00 | No | No | Current |