FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cayston
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui901610, 901614

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
458b18b0-b105-44ac-b090-378873a4e07bProduct name120251118
882349af-ee4e-3057-6dd7-68d0b142db19Product name220220608
74c5690d-3e83-e116-f1e7-47b67331bf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-0901-12025-03-18C16284748780-1c7ccaba7-1299-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use CAYSTON safely and effectively. See full prescribing information for CAYSTON. CAYSTON ® (aztreonam for inhalation solution), for oral inhalation use Initial U.S. Approval: 1986
61958-0901-12025-01-30C16284748780-1c7ccaba7-1299-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use CAYSTON safely and effectively. See full prescribing information for CAYSTON. CAYSTON ® (aztreonam for inhalation solution), for oral inhalation use Initial U.S. Approval: 1986
61958-0901-12021-07-23C16284748780-1c7ccaba7-1299-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use CAYSTON safely and effectively. See full prescribing information for CAYSTON. CAYSTON ® (aztreonam for inhalation solution), for oral inhalation use Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-0901-1Cayston1 in 1 CARTONKIT114
61958-0901-1Cayston2 in 1 PACKAGEKIT214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-0901-1ML - Milliliter61958-090148e28995-4e6d-4290-b56d-c6845376fb3012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aztreonamACTIVE INGREDIENTG2B4VE5GH8CAYSTON (AZTREONAM) KIT [GILEAD SCIENCES, INC.]8
aztreonamACTIVE MOIETYG2B4VE5GH8CAYSTON (AZTREONAM) KIT [GILEAD SCIENCES, INC.]8
lysine monohydrateINACTIVE INGREDIENTF7625B974UCAYSTON (AZTREONAM) KIT [GILEAD SCIENCES, INC.]8
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCAYSTON (AZTREONAM) KIT [GILEAD SCIENCES, INC.]8
waterINACTIVE INGREDIENT059QF0KO0RCAYSTON (AZTREONAM) KIT [GILEAD SCIENCES, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-0901CAYSTON (AZTREONAM) KIT [GILEAD SCIENCES, INC.]13Current NDC, Legacy NDC, 2 package rows20250321_67300ca3-8c53-4ce4-8e86-2c03be1f9b8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901610aztreonam 75 MG/ML Inhalation SolutionPSN67300ca3-8c53-4ce4-8e86-2c03be1f9b8a14
901614Cayston 75 MG/ML Inhalation SolutionPSN67300ca3-8c53-4ce4-8e86-2c03be1f9b8a14
901614aztreonam 75 MG/ML Inhalation Solution [Cayston]SBD67300ca3-8c53-4ce4-8e86-2c03be1f9b8a14
901610aztreonam 75 MG/ML Inhalation SolutionSCD67300ca3-8c53-4ce4-8e86-2c03be1f9b8a14
901614Cayston 75 MG/ML Inhalation SolutionSY67300ca3-8c53-4ce4-8e86-2c03be1f9b8a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61958-0901-1619580901012 CARTON in 1 PACKAGE (61958-0901-1) / 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE2 carton2010-02-220000-00-00NoNoCurrent