Home NDC 61958-0901 Cayston
Product NDC 61958-0901
11-digit product format 619580901
Labeler code 61958
Product ID 61958-0901_1485e37e-2b42-42bf-abb3-dd1241b02449
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name aztreonam
Dosage form KIT
Labeler Gilead Sciences, Inc.
Application NDA050814
Marketing category NDA
Marketing start 2010-02-22
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61958-0901-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61958-0901-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61958-0901-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61958-0901-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61958-0901-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N050814-001 CAYSTON AZTREONAM 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 cb3db0bc1861…
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 2019-12-13 00:20 UTC 2019-12 N050814-001 7208141 2021-12-20 U-1031 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050814-001 7214364 2021-12-20 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050814-001 7427633 2021-12-20 U-1031 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N050814-001 7208141 2021-12-20 U-1031 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050814-001 7214364 2021-12-20 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050814-001 7427633 2021-12-20 U-1031 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050814-001 7208141 2021-12-20 U-1031 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050814-001 7214364 2021-12-20 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050814-001 7427633 2021-12-20 U-1031 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050814-001 7208141 2021-12-20 U-1031 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050814-001 7214364 2021-12-20 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050814-001 7427633 2021-12-20 U-1031 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050814-001 7208141 2021-12-20 U-1031 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050814-001 7214364 2021-12-20 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050814-001 7427633 2021-12-20 U-1031 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050814-001 7208141 2021-12-20 U-1031 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050814-001 7214364 2021-12-20 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050814-001 7427633 2021-12-20 U-1031 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050814-001 7208141 2021-12-20 U-1031 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050814-001 7214364 2021-12-20 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050814-001 7427633 2021-12-20 U-1031 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050814-001 7208141 2021-12-20 U-1031 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050814-001 7214364 2021-12-20 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050814-001 7427633 2021-12-20 U-1031 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050814-001 7208141 2021-12-20 U-1031 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050814-001 7214364 2021-12-20 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050814-001 7427633 2021-12-20 U-1031 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Cayston
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 901610 Internal RxNorm lookup 901614 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61958-0901-1 Cayston 1 in 1 CARTON KIT 1 14 61958-0901-1 Cayston 2 in 1 PACKAGE KIT 2 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-0901 CAYSTON (AZTREONAM) KIT [GILEAD SCIENCES, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20250321_67300ca3-8c53-4ce4-8e86-2c03be1f9b8a.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61958-0901-1 61958090101 2 CARTON in 1 PACKAGE (61958-0901-1) / 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE 2 carton 2010-02-22 0000-00-00 No No Current