Home NDC 46708-057 Azithromycin
Product NDC 46708-057
11-digit product format 467080057
Labeler code 46708
Product ID 46708-057_bb31fbb2-b157-4333-ac3b-5f3d65039890
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA211791
Marketing category ANDA
Marketing start 2020-01-29
Substance AZITHROMYCIN DIHYDRATE
Active strength 250 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 A211791-001 AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211791-001 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.
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 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211791-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2020-01-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Azithromycin
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308460 Internal RxNorm lookup 749783 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 46708-057-06 Azithromycin 18 in 1 CARTON TABLET, FILM COATED 18 2 46708-057-06 Azithromycin 6 in 1 BLISTER PACK TABLET, FILM COATED 6 2 46708-057-18 Azithromycin 6 in 1 BLISTER PACK TABLET, FILM COATED 6 2 46708-057-18 Azithromycin 18 in 1 CARTON TABLET, FILM COATED 18 2 46708-057-30 Azithromycin 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-057 AZITHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 2 Current NDC, Legacy NDC, 5 package rows 20230113_deea1a56-84ed-4ce4-9d11-03271510c0a1.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 · 2 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 46708-057-06 46708005706 18 BLISTER PACK in 1 CARTON (46708-057-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK 18 blister pack 2020-01-29 0000-00-00 No No Current 46708-057-18 46708005718 18 BLISTER PACK in 1 CARTON (46708-057-18) / 6 TABLET, FILM COATED in 1 BLISTER PACK 18 blister pack 2020-01-29 0000-00-00 No No Current 46708-057-30 46708005730 30 TABLET, FILM COATED in 1 BOTTLE (46708-057-30) 2020-01-29 0000-00-00 No No Current