Home NDC 63323-402 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065439-001 AZTREONAM AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 A065439-002 AZTREONAM AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 A065439-003 AZTREONAM AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 4 · 123 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 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065439-002 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065439-003 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2010-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065439-001 AZTREONAM 500MG/VIAL INJECTABLE / INJECTION 2010-06-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Aztreonam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZTREONAM 2 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G2B4VE5GH8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1664981 Internal RxNorm lookup 1664986 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-402-01 Aztreonam 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 9 63323-402-20 Aztreonam 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 9 63323-402-24 Aztreonam 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 6 63323-402-41 Aztreonam 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 6 63323-402-03 Aztreonam 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 4 63323-402-30 Aztreonam 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZTREONAM ACTIVE INGREDIENT G2B4VE5GH8 AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 AZTREONAM ACTIVE MOIETY G2B4VE5GH8 AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 ARGININE INACTIVE INGREDIENT 94ZLA3W45F AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 AZTREONAM ACTIVE INGREDIENT G2B4VE5GH8 AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 AZTREONAM ACTIVE MOIETY G2B4VE5GH8 AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 ARGININE INACTIVE INGREDIENT 94ZLA3W45F AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 AZTREONAM ACTIVE INGREDIENT G2B4VE5GH8 AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 AZTREONAM ACTIVE MOIETY G2B4VE5GH8 AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 ARGININE INACTIVE INGREDIENT 94ZLA3W45F AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-402 AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 9 Current NDC, Legacy NDC, 2 package rows 20220412_c6cf7e13-a04e-47e2-9cec-44a278ee6bec.zip 63323-402 AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 6 Current NDC, Legacy NDC, 2 package rows 20220604_5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18.zip 63323-402 AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 4 Current NDC, Legacy NDC, 2 package rows 20220602_302fd27d-0a22-44ea-91fb-1b1ffcf17a1f.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 · 3 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 63323-402-01 63323040201 1 in 1 VIAL Historical 63323-402-03 63323040203 1 in 1 VIAL Historical 63323-402-20 63323040220 10 VIAL in 1 TRAY (63323-402-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-402-01) 10 vial 2009-11-05 0000-00-00 No No Current 63323-402-24 63323040224 10 VIAL in 1 TRAY (63323-402-24) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-402-41) 10 vial 2009-11-05 0000-00-00 No No Current 63323-402-30 63323040230 10 VIAL in 1 TRAY (63323-402-30) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-402-03) 10 vial 2009-11-05 0000-00-00 No No Current 63323-402-41 63323040241 1 in 1 VIAL Historical