Bosentan
- Product NDC
- 68180-387
- 11-digit product format
- 681800387
- Labeler code
- 68180
- Product ID
- 68180-387_7dd72f02-4300-434a-a67c-f6ab1cff4991
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosentan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA206987
- Marketing category
- ANDA
- Marketing start
- 2019-04-26
- Marketing end
- 0000-00-00
- Substance
- BOSENTAN
- Active strength
- 63 mg/1
- Pharmacologic classes
- Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-387-07 | 68180038707 | 60 TABLET in 1 BOTTLE (68180-387-07) | 60 tablet | 2019-04-26 | 0000-00-00 | No | No | Current |