Home NDC 64679-961-08 Azithromycin
Product NDC 64679-961
Requested package NDC 64679-961-08
11-digit product format 646790961
Labeler code 64679
Product ID 64679-961_d2a1950b-4358-ad27-e053-2a95a90a7f92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt USA LLC.
Application ANDA065404
Marketing category ANDA
Marketing start 2008-02-11
Marketing end 0000-00-00
Substance AZITHROMYCIN ANHYDROUS
Active strength 250 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 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 A065404-001 AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065404-001 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 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065404-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2008-02-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64679-961-01 2024-11-14 These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991 64679-961-02 2024-11-14 These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991 64679-961-05 2024-11-14 These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991 64679-961-07 2024-11-14 These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991 64679-961-08 2024-11-14 These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991 64679-961-01 2023-01-30 These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991 64679-961-02 2023-01-30 These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991 64679-961-05 2023-01-30 These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991 64679-961-07 2023-01-30 These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991 64679-961-08 2023-01-30 These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Azithromycin Anhydrous ACTIVE INGREDIENT J2KLZ20U1M AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Azithromycin Anhydrous ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Croscarmellose Sodium INACTIVE INGREDIENT M28OL1HH48 AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Hydroxypropyl Cellulose (type H) INACTIVE INGREDIENT RFW2ET671P AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Magnesium Trisilicate INACTIVE INGREDIENT C2E1CI501T AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK] 15 AZITHROMYCIN ANHYDROUS ACTIVE INGREDIENT J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 MAGNESIUM TRISILICATE INACTIVE INGREDIENT C2E1CI501T AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 AZITHROMYCIN ANHYDROUS ACTIVE INGREDIENT J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 AZITHROMYCIN ANHYDROUS ACTIVE INGREDIENT J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [RXCHANGE CO.] 2 AZITHROMYCIN ANHYDROUS ACTIVE INGREDIENT J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [RXCHANGE CO.] 2 AZITHROMYCIN ANHYDROUS ACTIVE INGREDIENT J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 AZITHROMYCIN ANHYDROUS ACTIVE INGREDIENT J2KLZ20U1M AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 AZITHROMYCIN ANHYDROUS ACTIVE INGREDIENT J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 AZITHROMYCIN ACTIVE MOIETY F94OW58Y8V AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 AZITHROMYCIN ACTIVE MOIETY F94OW58Y8V AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64679-961-08 64679096108 3500 TABLET, FILM COATED in 1 BAG (64679-961-08) 2015-07-28 0000-00-00 No No Current