Orange Book product · Brand (NDA)
TECHNEGAS KIT
TECHNETIUM TC-99M LABELED CARBON
At a glance
Sep 29, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 29, 2023
2 yr 9 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Sep 29, 2026
in 3 mo
Patent 7722856 expires
Listed method-of-use patent (U-4442) expiration.
Feb 24, 2031
in 4 yr 9 mo
Pharmaceutical detail
Active ingredient
TECHNETIUM TC-99M LABELED CARBON
Strength
N/A
Dosage form
AEROSOL
Route
INHALATION
TE code
Not listed
Application
NDA 022335
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Sep 29, 2026
in 3 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7722856 | Feb 24, 2031 | in 4 yr 9 mo | U-4442 |

