Home NDC 71093-175 Azithromycin Dihydrate
Product NDC 71093-175
11-digit product format 710930175
Labeler code 71093
Product ID 71093-175_77a7e874-29c3-449c-92b3-448023e67197
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin Dihydrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ACI Healthcare USA, Inc.
Application ANDA215773
Marketing category ANDA
Marketing start 2023-07-30
Substance AZITHROMYCIN DIHYDRATE
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 A215773-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2022-07-12
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.
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 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2022-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2022-07-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2022-07-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2022-07-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2022-07-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2022-07-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2022-07-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2022-07-12 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215773-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2022-07-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Azithromycin Dihydrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZITHROMYCIN DIHYDRATE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5FD1131I7S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248656 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 71093-175-01 Azithromycin Dihydrate 30 in 1 BOTTLE TABLET, FILM COATED 30 6 71093-175-05 Azithromycin Dihydrate 500 in 1 BOTTLE TABLET, FILM COATED 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71093-175 AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [ACI HEALTHCARE USA, INC.] 6 Current NDC, 2 package rows 20231213_fb2f83a2-507b-4cf3-81ea-d10c46c0f8ea.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 Sample Exclude flag Status 71093-175-01 71093017501 30 TABLET, FILM COATED in 1 BOTTLE (71093-175-01) 2023-09-30 No No Current 71093-175-05 71093017505 500 TABLET, FILM COATED in 1 BOTTLE (71093-175-05) 2023-09-30 No No Current