Home NDC 0409-0144-11 Azithromycin
Product NDC 0409-0144
Requested package NDC 0409-0144-11
11-digit product format 004090144
Labeler code 0409
Product ID 0409-0144_0daee3b8-efec-4ff2-aedf-87035563373f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AZITHROMYCIN
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA065500
Marketing category ANDA
Marketing start 2009-06-26
Substance AZITHROMYCIN MONOHYDRATE
Active strength 500 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [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 42 .
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 A065500-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065500-001 AP
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 · 42 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 2026-08-18 06:07:40 2026-07 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065500-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-06-26 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-0144-11 Azithromycin 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 30 0409-0144-21 Azithromycin 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 17 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 17 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 17 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 17 AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 15 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 15 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 15 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-0144 AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 30 Current NDC, Legacy NDC, 2 package rows 20250418_d2f4907f-b952-403b-229e-cc5b8327a773.zip
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 0409-0144-11 00409014411 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-0144-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0144-21) 2009-06-26 0000-00-00 No No Current