Home NDC 55150-174 Azithromycin
Product NDC 55150-174
11-digit product format 551500174
Labeler code 55150
Product ID 55150-174_6760771b-9c61-458d-9778-81a3da96cb9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA203294
Marketing category ANDA
Marketing start 2015-06-19
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 1 .
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 A203294-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203294-001 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 · 41 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 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203294-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-06-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Azithromycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZITHROMYCIN MONOHYDRATE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JTE4MNN1MD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1668238 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 55150-174-10 Azithromycin 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 13 55150-174-10 Azithromycin 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AUROMEDICS PHARMA LLC] 2 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AUROMEDICS PHARMA LLC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AUROMEDICS PHARMA LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AUROMEDICS PHARMA LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-174 AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] 13 Current NDC, Legacy NDC, 2 package rows 20230725_7b81436e-d14a-4353-a22d-253f45e2e576.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 55150-174-10 55150017410 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2015-06-19 0000-00-00 No No Current