NDC 61958-0802
Letairis
Ambrisentan
Letairis is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc. The primary component is Ambrisentan.
| Product ID | 61958-0802_836eb5a8-9233-4be6-a2ff-57a979211aa9 |
| NDC | 61958-0802 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Letairis |
| Generic Name | Ambrisentan |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2007-06-15 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022081 |
| Labeler Name | Gilead Sciences, Inc |
| Substance Name | AMBRISENTAN |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 61958-0802-1
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0802-1)
| Marketing Start Date | 2007-06-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 61958-0802-1 [61958080201]
Letairis TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA022081 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2007-06-15 |
NDC 61958-0802-2 [61958080202]
Letairis TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA022081 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2007-06-15 |
NDC 61958-0802-5 [61958080205]
Letairis TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA022081 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2007-06-15 |
NDC 61958-0802-3 [61958080203]
Letairis TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA022081 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2007-06-15 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| AMBRISENTAN | 10 mg/1 |
OpenFDA Data
| SPL SET ID: | 725d4e73-6c83-477a-adc6-0ae4a133a844 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Endothelin Receptor Antagonist [EPC]
- Endothelin Receptor Antagonists [MoA]
NDC Crossover Matching brand name "Letairis" or generic name "Ambrisentan"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 61958-0801 | Letairis | AMBRISENTAN |
| 61958-0802 | Letairis | AMBRISENTAN |
| 0378-4270 | Ambrisentan | ambrisentan |
| 0378-4271 | Ambrisentan | ambrisentan |
| 0591-2405 | Ambrisentan | Ambrisentan |
| 0591-2406 | Ambrisentan | Ambrisentan |
| 42291-018 | AMBRISENTAN | AMBRISENTAN |
| 42291-019 | AMBRISENTAN | AMBRISENTAN |
| 42794-051 | AMBRISENTAN | AMBRISENTAN |
| 42794-052 | AMBRISENTAN | AMBRISENTAN |
| 47335-236 | ambrisentan | ambrisentan |
| 47335-237 | ambrisentan | ambrisentan |
| 49884-353 | Ambrisentan | Ambrisentan |
| 49884-354 | Ambrisentan | Ambrisentan |
| 59651-494 | ambrisentan | ambrisentan |
| 59651-495 | ambrisentan | ambrisentan |
| 60505-4552 | Ambrisentan | AMBRISENTAN |
| 60505-4553 | Ambrisentan | AMBRISENTAN |
| 69097-386 | Ambrisentan | Ambrisentan |
| 69097-387 | Ambrisentan | Ambrisentan |
Trademark Results [Letairis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LETAIRIS 78521260 3395796 Live/Registered |
GILEAD COLORADO, INC. 2004-11-22 |
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