Home NDC 70518-3094-0 azithromycin
Product NDC 70518-3094
Requested package NDC 70518-3094-0
11-digit product format 705183094
Labeler code 70518
Product ID 70518-3094_d0fe1360-a324-6a16-e053-2995a90a05c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AZITHROMYCIN MONOHYDRATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA209044
Marketing category ANDA
Marketing start 2021-05-13
Marketing end 0000-00-00
Substance AZITHROMYCIN MONOHYDRATE
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-3094 70518-3094-0 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-3094 70518-3094-0 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 A209044-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209044-001 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 · 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 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209044-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-12-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3094 AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) TABLET, FILM COATED [REMEDYREPACK INC.] 6 Legacy NDC 20240927_89a8e05f-b60c-4b8f-96c4-d49222163fbc.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-3094-0 70518309400 2 POUCH in 1 BOX (70518-3094-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3094-1) 2 pouch 2021-05-13 0000-00-00 No No Current