Home NDC 68788-8124 Azithromycin
Product NDC 68788-8124
11-digit product format 687888124
Labeler code 68788
Product ID 68788-8124_661ff7a6-6394-493d-a307-a1f607e5d117
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA065211
Marketing category ANDA
Marketing start 2022-01-10
Marketing end 0000-00-00
Substance AZITHROMYCIN MONOHYDRATE
Active strength 250 mg/1
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 · 30 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 68788-8124-6 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 68788-8124-6 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 68788-8124-6 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 68788-8124-6 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 68788-8124-6 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 68788-8124-6 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 68788-8124-6 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 68788-8124-6 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 68788-8124-6 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68788-8124-6 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68788-8124-6 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68788-8124-6 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68788-8124-6 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68788-8124-6 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68788-8124-6 1332a3947898…d4bfe170f9cd…
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 A065211-001 AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065211-001 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 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065211-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Azithromycin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZITHROMYCIN DIHYDRATE 250 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248656 Internal RxNorm lookup 308460 Internal RxNorm lookup 749780 Internal RxNorm lookup 749783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8124-6 Azithromycin 1 in 1 DOSE PACK TABLET, FILM COATED 1 1 68788-8124-6 Azithromycin 6 in 1 CARTON TABLET, FILM COATED 6 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8124 AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] 1 Legacy NDC, 2 package rows 20220111_661ff7a6-6394-493d-a307-a1f607e5d117.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-8124-6 68788812406 6 DOSE PACK in 1 CARTON (68788-8124-6) > 1 TABLET, FILM COATED in 1 DOSE PACK 6 dose pack 2022-01-10 0000-00-00 No No Current