BOSENTAN
- Product NDC
- 69097-377
- 11-digit product format
- 690970377
- Labeler code
- 69097
- Product ID
- 69097-377_252ae260-45e5-4477-a702-830e83a16072
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bosentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA210342
- Marketing category
- ANDA
- Marketing start
- 2020-01-03
- Marketing end
- 0000-00-00
- Substance
- BOSENTAN
- Active strength
- 63 mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69097-377-03 | 69097037703 | 60 TABLET, FILM COATED in 1 BOTTLE (69097-377-03) | | 2020-01-03 | 0000-00-00 | No | No | Current |
| 69097-377-76 | 69097037776 | 1 BLISTER PACK in 1 CARTON (69097-377-76) > 14 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2020-01-03 | 0000-00-00 | No | No | Current |