Home NDC 0781-8091 Azithromycin
Product NDC 0781-8091
11-digit product format 007818091
Labeler code 0781
Product ID 0781-8091_5cec3961-a2a4-4f61-a73e-1656021b4195
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA065209
Marketing category ANDA
Marketing start 2005-11-14
Substance AZITHROMYCIN DIHYDRATE
Active strength 600 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A065209-001 AZITHROMYCIN AZITHROMYCIN EQ 600MG 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 A065209-001 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 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065209-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2005-11-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065209-001 AZITHROMYCIN EQ 600MG 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZITHROMYCIN DIHYDRATE 600 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204844 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-8091-31 Azithromycin 30 in 1 BOTTLE TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-8091 AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC] 4 Current NDC, Legacy NDC, 1 package rows 20220205_34b70c23-92a6-460f-8dbb-15a0e6b9d3a9.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 · 1 matching rows.
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 0781-8091-31 00781809131 30 TABLET, FILM COATED in 1 BOTTLE (0781-8091-31) 2019-02-14 0000-00-00 No No Current