Home NDC 76420-589 Azithromycin
Product NDC 76420-589
11-digit product format 764200589
Labeler code 76420
Product ID 76420-589_04472220-f8c1-1f1a-e063-6294a90a2bb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA065223
Marketing category ANDA
Marketing start 2006-01-06
Substance AZITHROMYCIN MONOHYDRATE
Active strength 500 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A065223-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065223-001 AB
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 · 44 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 2026-10-15 13:18:30 2026-09 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Azithromycin
Listing expiration 2027-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248656 Internal RxNorm lookup 308460 Internal RxNorm lookup 749780 Internal RxNorm lookup 749783 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 76420-589-03 Azithromycin 3 in 1 BLISTER PACK TABLET, FILM COATED 3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-589 AZITHROMYCIN TABLET, FILM COATED [ASCLEMED USA, INC.] 3 Current NDC, 1 package rows 20230902_9c44af6d-8a9a-cb4c-e053-2a95a90afdac.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 · 4 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 76420-589-03 76420058903 3 TABLET, FILM COATED in 1 BLISTER PACK (76420-589-03) 2023-09-01 No No Current