Home NDC 43986-005 Azithromycin
Product NDC 43986-005
11-digit product format 439860005
Labeler code 43986
Product ID 43986-005_81dfb974-e96e-caba-e053-2a91aa0ab7f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form TABLET
Route ORAL
Labeler Bluepharma - Industria Farmaceutica, S.A.
Application ANDA209999
Marketing category ANDA
Marketing start 2019-03-01
Marketing end 0000-00-00
Substance AZITHROMYCIN DIHYDRATE
Active strength 600 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 43986-005 Y Unknown FDA exclusion code: Y excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 43986-005 43986-005-01 Y Unknown FDA exclusion code: Y excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 A209999-001 AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209999-001 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 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209999-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-12-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.