Home NDC 0409-0830 Aztreonam
Product NDC 0409-0830
11-digit product format 004090830
Labeler code 0409
Product ID 0409-0830_8664bd65-dcd7-420f-a8e3-01eaf3e02b36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aztreonam
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA206517
Marketing category ANDA
Marketing start 2022-01-24
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206517-001 AZTREONAM AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 A206517-002 AZTREONAM AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08
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 2 · 66 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 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206517-001 AZTREONAM 1GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206517-002 AZTREONAM 2GM/VIAL INJECTABLE / INJECTION AP 2021-11-08 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 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 0409-0830-01 Aztreonam 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 3 0409-0830-11 Aztreonam 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-0830 AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240616_d4500795-3b07-4a7d-b432-73cafbb3dbc6.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 Marketing start Marketing end Sample Exclude flag Status 0409-0830-01 00409083001 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0830-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0830-11) 2022-01-24 0000-00-00 No No Current 0409-0830-11 00409083011 1 in 1 VIAL, SINGLE-DOSE Historical