Ondansetron
- Product NDC
- 63850-0004
- 11-digit product format
- 638500004
- Labeler code
- 63850
- Product ID
- 63850-0004_04819dac-e9c5-4d65-b8e4-15a1fd5a93c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Natco Pharma Limited
- Application
- ANDA077851
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ondansetron
- 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 | 198052, 312086 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63850-0004-1 | Ondansetron | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63850-0004 | ONDANSETRON (ONDANSETRON TABLETS) TABLET, FILM COATED [NATCO PHARMA LIMITED] | 9 | Current NDC, Legacy NDC, 1 package rows | 20211130_59c817b7-a1c6-48a5-9bfc-2c381532bfd9.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 |
|---|
| 63850-0004-1 | 63850000401 | 30 TABLET, FILM COATED in 1 BOTTLE (63850-0004-1) | 2007-06-25 | 0000-00-00 | No | No | Current |