Home NDC 80425-0412 azithromycin dihydrate
Product NDC 80425-0412
11-digit product format 804250412
Labeler code 80425
Product ID 80425-0412_1d0e96cf-245e-cfb7-e063-6294a90a4ced
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azithromycin dihydrate
Dosage form TABLET
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Application ANDA065399
Marketing category ANDA
Marketing start 2024-07-10
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 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 A065399-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065399-001 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 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065399-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2015-05-15 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248656 Internal RxNorm lookup 749780 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 80425-0412-1 azithromycin dihydrate 3 in 1 BLISTER PACK TABLET 3 2 80425-0412-1 azithromycin dihydrate 1 in 1 CARTON TABLET 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0412 AZITHROMYCIN DIHYDRATE TABLET [ADVANCED RX OF TENNESSEE, LLC] 2 Current NDC, 2 package rows 20240716_1cec44fa-9597-3e58-e063-6394a90ae326.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 Units Marketing start Sample Exclude flag Status 80425-0412-1 80425041201 1 BLISTER PACK in 1 CARTON (80425-0412-1) / 3 TABLET in 1 BLISTER PACK 1 blister pack 2024-07-10 No No Current