Ondansetron Hydrochloride
- Product NDC
- 43063-792
- 11-digit product format
- 430630792
- Labeler code
- 43063
- Product ID
- 43063-792_3ed9a18c-3975-d837-e063-6394a90a8f1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078539
- Marketing category
- ANDA
- Marketing start
- 2007-07-31
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ondansetron Hydrochloride
- Listing expiration
- 2026-12-31
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 |
|---|
| 43063-792-06 | Ondansetron Hydrochloride | 6 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 6 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-792 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 18 | Current NDC, Legacy NDC, 1 package rows | 20241109_0b675b09-fe40-435c-b91a-c61cdf767fbf.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 |
|---|
| 43063-792-06 | 43063079206 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-792-06) | 2017-10-06 | 0000-00-00 | No | No | Current |