Home NDC 68180-162-06 azithromycin monohydrate
Product NDC 68180-162
Requested package NDC 68180-162-06
11-digit product format 681800162
Labeler code 68180
Product ID 68180-162_e6e8dd21-bd53-43d4-80d1-61eb0ba449c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azithromycin monohydrate
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA065400
Marketing category ANDA
Marketing start 2015-08-18
Marketing end 2024-05-31
Substance AZITHROMYCIN MONOHYDRATE
Active strength 600 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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, 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 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68180-162 68180-162-06 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68180-162 68180-162-06 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 A065400-001 AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065400-001 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 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065400-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2015-05-15 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 · 2 matching rows.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 4 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 4 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J AZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 4 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W AZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 AZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-162-06 68180016206 30 TABLET in 1 CONTAINER (68180-162-06) 30 tablet 2015-08-18 2024-05-31 No No Current