Home NDC 71093-174 Azithromycin Dihydrate
Product NDC 71093-174
11-digit product format 710930174
Labeler code 71093
Product ID 71093-174_5df20b25-1932-414b-b028-210e839c1c38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin Dihydrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ACI Healthcare USA, Inc.
Application ANDA215772
Marketing category ANDA
Marketing start 2022-12-01
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 42 .
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 A215772-001 AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2022-07-15
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 2026-08-18 06:07:40 2026-07 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2022-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2022-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2022-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2022-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2022-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2022-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2022-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2022-07-15 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215772-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2022-07-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Azithromycin Dihydrate
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308460 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 71093-174-01 Azithromycin Dihydrate 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 71093-174 AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [ACI HEALTHCARE USA, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20231213_39a808c4-72ac-48e4-bfb8-e5ae3429b225.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 71093-174-01 71093017401 30 TABLET, FILM COATED in 1 BOTTLE (71093-174-01) 2022-12-01 0000-00-00 No No Current