Home NDC 59651-008 Azithromycin
Product NDC 59651-008
11-digit product format 596510008
Labeler code 59651
Product ID 59651-008_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA209201
Marketing category ANDA
Marketing start 2018-10-09
Substance AZITHROMYCIN DIHYDRATE
Active strength 200 mg/5mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209201-001 AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 A209201-002 AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209201-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209201-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2018-10-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 200 mg/5mL
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 141963 Internal RxNorm lookup 308459 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 59651-008-15 Azithromycin 15 mL in 1 BOTTLE POWDER, FOR SUSPENSION 15 8 59651-008-15 Azithromycin 1 in 1 CARTON POWDER, FOR SUSPENSION 1 8 59651-008-23 Azithromycin 22.5 mL in 1 BOTTLE POWDER, FOR SUSPENSION 22.5 8 59651-008-23 Azithromycin 1 in 1 CARTON POWDER, FOR SUSPENSION 1 8 59651-008-30 Azithromycin 30 mL in 1 BOTTLE POWDER, FOR SUSPENSION 30 8 59651-008-30 Azithromycin 1 in 1 CARTON POWDER, FOR SUSPENSION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-008 AZITHROMYCIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 8 Current NDC, Legacy NDC, 6 package rows 20220523_3c902990-b870-4725-b9fe-76b8be633e1c.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 Units Marketing start Marketing end Sample Exclude flag Status 59651-008-15 59651000815 1 BOTTLE in 1 CARTON (59651-008-15) / 15 mL in 1 BOTTLE 1 bottle 2018-10-09 0000-00-00 No No Current 59651-008-23 59651000823 1 BOTTLE in 1 CARTON (59651-008-23) / 22.5 mL in 1 BOTTLE 1 bottle 2018-10-09 0000-00-00 No No Current 59651-008-30 59651000830 1 BOTTLE in 1 CARTON (59651-008-30) / 30 mL in 1 BOTTLE 1 bottle 2018-10-09 0000-00-00 No No Current