Home NDC 68788-8222 Azithromycin
Product NDC 68788-8222
11-digit product format 687888222
Labeler code 68788
Product ID 68788-8222_1f803eed-f13c-4d5e-a058-67aaa0caed9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA209201
Marketing category ANDA
Marketing start 2022-09-09
Marketing end 0000-00-00
Substance AZITHROMYCIN DIHYDRATE
Active strength 200 mg/5mL
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68788-8222-3 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68788-8222-3 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68788-8222-3 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68788-8222-3 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68788-8222-3 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68788-8222-3 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68788-8222-3 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68788-8222-3 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-8222-3 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209201-001 AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 A209201-002 AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-8222-3 68788822203 1 BOTTLE in 1 CARTON (68788-8222-3) > 30 mL in 1 BOTTLE 1 bottle 2022-09-09 0000-00-00 No No Current