Home NDC 67296-0020-1 Zithromax
Product NDC 67296-0020
Requested package NDC 67296-0020-1
11-digit product format 672960020
Labeler code 67296
Product ID 67296-0020_3ddecd2f-ea4c-536f-e063-6294a90a7936
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azithromycin dihydrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Redpharm Drug
Application NDA050711
Marketing category NDA
Marketing start 1996-07-18
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 N050711-001 ZITHROMAX AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050711-001 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 · 41 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 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050711-001 ZITHROMAX EQ 250MG BASE TABLET / ORAL AB RLD 1996-07-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zithromax
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 212446 Internal RxNorm lookup 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 67296-0020-1 Zithromax 4 in 1 BOTTLE TABLET, FILM COATED 4 1 67296-0020-2 Zithromax 6 in 1 BOTTLE TABLET, FILM COATED 6 1
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 67296-0020-1 67296002001 4 TABLET, FILM COATED in 1 BOTTLE (67296-0020-1) 1996-07-18 No No Current