Home NDC 73814-989 TECHNEGAS
Product NDC 73814-989
11-digit product format 738140989
Labeler code 73814
Product ID 73814-989_4a80a439-074a-c62f-e063-6394a90a7834
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol
Dosage form KIT
Labeler Cyclomedica Australia Pty Limited
Application NDA022335
Marketing category NDA
Marketing start 2023-09-29
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022335-001 TECHNEGAS KIT TECHNETIUM TC-99M LABELED CARBON N/A AEROSOL / INHALATION RLD, RS 2023-09-29
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022335-001 7722856 2031-02-24 U-4442 2026-03-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N022335-001 NP 2026-09-29
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022335-001 7722856 2031-02-24 U-4442 2026-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022335-001 7722856 2031-02-24 U-4442 2026-03-13 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022335-001 7722856 2031-02-24 U-4442 2026-03-13 a50c72e98297…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TECHNEGAS
Listing expiration 2027-12-31 Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73814-986-20 TECHNEGAS 50 in 1 CARTON AEROSOL 1 1.25 g 2 73814-989-20 TECHNEGAS 1 in 1 CARTON KIT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73814-989 TECHNEGAS (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M-LABELED CARBON INHALATION AEROSOL) KIT [CYCLOMEDICA AUSTRALIA PTY LIMITED] 1 Current NDC, 2 package rows 20240209_10ab1c14-3e01-e12b-e063-6394a90aea2f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TECHNEGAS KIT FOR THE PREPARATION OF TECHNETIUM TC 99M-LABELED CARBON INHALATION AEROSOL Cyclomedica Australia Pty Limited 10ab1c14-3e01-e12b-e063-6394a90aea2f 2026-02-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 022335 application number: NDA022335 ndc (product): 73814-989 TECHNEGAS KIT FOR THE PREPARATION OF TECHNETIUM TC 99M-LABELED CARBON INHALATION AEROSOL Cyclomedica Australia Pty Limited 10320da4-0c64-4d03-e063-6394a90a1923 2026-02-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 022335 application number: NDA022335
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73814-986-20 73814098620 50 in 1 CARTON Historical 73814-989-20 73814098920 1 KIT in 1 CARTON (73814-989-20) * 50 in 1 CARTON (GS1:19340598000036) * 50 AEROSOL in 1 CARTON (73814-986-20) 1 kit 2023-09-29 No No Current