Home NDC 63126-402-30 AZITHROMYCIN DIHYDRATE
Product NDC 63126-402
Requested package NDC 63126-402-30
11-digit product format 631260402
Labeler code 63126
Product ID 63126-402_171d7bd6-0435-4ffb-b126-e3f966433b0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AZITHROMYCIN DIHYDRATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Yung Shin Pharmaceutical Ind. Co., Ltd.
Application ANDA211318
Marketing category ANDA
Marketing start 2021-08-31
Marketing end 0000-00-00
Substance AZITHROMYCIN DIHYDRATE
Active strength 500 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A211318-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17
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 2026-09-14 22:38:34 2026-08 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2021-03-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2021-03-17 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211318-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL 2021-03-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2021-12-28 21:50 UTC 2021-12 A211318-001 AB 1 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211318-001 AB 1 87673890dc5c…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63126-402-30 63126040230 30 TABLET, FILM COATED in 1 BOTTLE (63126-402-30) 2021-08-31 0000-00-00 No No Current