Home NDC 70518-4202 Azithromycin Dihydrate
Product NDC 70518-4202
11-digit product format 705184202
Labeler code 70518
Product ID 70518-4202_5a58842d-b268-69b6-e063-6294a90a0dd3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin dihydrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA207566
Marketing category ANDA
Marketing start 2024-10-02
Substance AZITHROMYCIN DIHYDRATE
Active strength 600 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A207566-001 AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207566-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207566-001 AZITHROMYCIN EQ 600MG BASE TABLET / ORAL AB 2018-09-24 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Azithromycin Dihydrate
Listing expiration 2027-12-31 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 70518-4202-0 Azithromycin Dihydrate 30 in 1 BLISTER PACK TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4202 AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REMEDYREPACK INC.] 1 Current NDC, 1 package rows 20241004_0d5129e4-8b94-4a4d-baa9-be0d6b32d714.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 Marketing start Sample Exclude flag Status 70518-4202-0 70518420200 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4202-0) 2024-10-02 No No Current