FDA.reportPublic FDA data

Aztreonam

Product NDC
63323-402
11-digit product format
633230402
Labeler code
63323
Product ID
63323-402_6cd42e51-1a5d-4c6a-8881-0cbde3ca8d70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZTREONAM
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA065439
Marketing category
ANDA
Marketing start
2009-11-05
Substance
AZTREONAM
Active strength
2 g/1
Pharmacologic classes
Monobactam Antibacterial [EPC], Monobactams [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZTREONAM2 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2B4VE5GH8
Rxcui1664981, 1664986

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
458b18b0-b105-44ac-b090-378873a4e07bProduct name120251118
882349af-ee4e-3057-6dd7-68d0b142db19Product name220220608
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
74c5690d-3e83-e116-f1e7-47b67331bf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-402-01Aztreonam1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,19
63323-402-20Aztreonam10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,109
63323-402-24Aztreonam10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,106
63323-402-41Aztreonam1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,16
63323-402-03Aztreonam1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,14
63323-402-30Aztreonam10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-402-01EA - Each63323-402b23a6f85-5a3f-4639-931d-27d3d8cd43cf12021-10-08
63323-402-03EA - Each63323-402829e5b27-333e-427f-919f-4d835ae77d4612022-02-07
63323-402-20EA - Each63323-40211dc9e32-70b9-47f0-a852-8186ac23864212012-07-24
63323-402-24EA - Each63323-40236267525-0323-4e58-baf3-e73179fae05912014-09-03
63323-402-30EA - Each63323-4029d05de5c-f22e-4c17-a1ca-658b3027f56f12015-06-09
63323-402-41EA - Each63323-402ee9a0d12-2968-41dd-87cf-6602206419fb12022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZTREONAMACTIVE INGREDIENTG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
AZTREONAMACTIVE MOIETYG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
ARGININEINACTIVE INGREDIENT94ZLA3W45FAZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
AZTREONAMACTIVE INGREDIENTG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
AZTREONAMACTIVE MOIETYG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
ARGININEINACTIVE INGREDIENT94ZLA3W45FAZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
AZTREONAMACTIVE INGREDIENTG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
AZTREONAMACTIVE MOIETYG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
ARGININEINACTIVE INGREDIENT94ZLA3W45FAZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-402AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]9Current NDC, Legacy NDC, 2 package rows20220412_c6cf7e13-a04e-47e2-9cec-44a278ee6bec.zip
63323-402AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20220604_5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18.zip
63323-402AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20220602_302fd27d-0a22-44ea-91fb-1b1ffcf17a1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1664981aztreonam 1 GM InjectionPSNc6cf7e13-a04e-47e2-9cec-44a278ee6bec9
1664986aztreonam 2 GM InjectionPSNc6cf7e13-a04e-47e2-9cec-44a278ee6bec9
1664981aztreonam 1000 MG InjectionSCDc6cf7e13-a04e-47e2-9cec-44a278ee6bec9
1664986aztreonam 2000 MG InjectionSCDc6cf7e13-a04e-47e2-9cec-44a278ee6bec9
1664981aztreonam 1 GM InjectionPSN5f5ebb63-6ac5-4fb4-bcc1-d069c123eb186
1664986aztreonam 2 GM InjectionPSN5f5ebb63-6ac5-4fb4-bcc1-d069c123eb186
1664981aztreonam 1000 MG InjectionSCD5f5ebb63-6ac5-4fb4-bcc1-d069c123eb186
1664986aztreonam 2000 MG InjectionSCD5f5ebb63-6ac5-4fb4-bcc1-d069c123eb186
1664981aztreonam 1 GM InjectionPSN302fd27d-0a22-44ea-91fb-1b1ffcf17a1f4
1664986aztreonam 2 GM InjectionPSN302fd27d-0a22-44ea-91fb-1b1ffcf17a1f4
1664981aztreonam 1000 MG InjectionSCD302fd27d-0a22-44ea-91fb-1b1ffcf17a1f4
1664986aztreonam 2000 MG InjectionSCD302fd27d-0a22-44ea-91fb-1b1ffcf17a1f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-402-01633230402011 in 1 VIALHistorical
63323-402-03633230402031 in 1 VIALHistorical
63323-402-206332304022010 VIAL in 1 TRAY (63323-402-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-402-01) 10 vial2009-11-050000-00-00NoNoCurrent
63323-402-246332304022410 VIAL in 1 TRAY (63323-402-24) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-402-41) 10 vial2009-11-050000-00-00NoNoCurrent
63323-402-306332304023010 VIAL in 1 TRAY (63323-402-30) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-402-03) 10 vial2009-11-050000-00-00NoNoCurrent
63323-402-41633230402411 in 1 VIALHistorical