Home NDC 62135-705 Azithromycin
Product NDC 62135-705
11-digit product format 621350705
Labeler code 62135
Product ID 62135-705_15af5062-22b6-c8b6-e063-6294a90a7df3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form SUSPENSION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA065488
Marketing category ANDA
Marketing start 2015-05-15
Substance AZITHROMYCIN MONOHYDRATE
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 A065488-001 AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 A065488-002 AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15
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 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 782e0a99824c…
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 MONOHYDRATE 200 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JTE4MNN1MD 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 62135-705-43 Azithromycin 30 mL in 1 BOTTLE SUSPENSION 30 1 62135-705-51 Azithromycin 15 mL in 1 BOTTLE SUSPENSION 15 1 62135-705-52 Azithromycin 22.5 mL in 1 BOTTLE SUSPENSION 22.5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-705 AZITHROMYCIN SUSPENSION [CHARTWELL RX, LLC] 1 Current NDC, 3 package rows 20240410_2c9de2e9-c20c-4660-a272-a22019f9fb02.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 Sample Exclude flag Status 62135-705-43 62135070543 30 mL in 1 BOTTLE (62135-705-43) 30 ml 2024-03-07 No No Current 62135-705-51 62135070551 15 mL in 1 BOTTLE (62135-705-51) 15 ml 2024-03-07 No No Current 62135-705-52 62135070552 22.5 mL in 1 BOTTLE (62135-705-52) 22.5 ml 2024-03-07 No No Current