Ondansetron
- Product NDC
- 0378-0315
- 11-digit product format
- 003780315
- Labeler code
- 0378
- Product ID
- 0378-0315_f80f6db7-f367-4a60-8347-cbb96adb5f34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076930
- Marketing category
- ANDA
- Marketing start
- 2007-06-25
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0315-01 | 00378031501 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0315-01) | 2007-06-25 | 0000-00-00 | No | No | Current |
| 0378-0315-05 | 00378031505 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0315-05) | 2007-06-25 | 0000-00-00 | No | No | Current |
| 0378-0315-93 | 00378031593 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0315-93) | 2007-06-25 | 0000-00-00 | No | No | Current |