Home NDC 0069-4061 Zithromax
Product NDC 0069-4061
11-digit product format 000694061
Labeler code 0069
Product ID 0069-4061_e15f2173-8700-4392-96a4-8560772b6f8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azithromycin dihydrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA050711
Marketing category NDA
Marketing start 2019-05-17
Substance AZITHROMYCIN DIHYDRATE
Active strength 250 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 2027-12-31 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 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105260 Internal RxNorm lookup 141963 Internal RxNorm lookup 211307 Internal RxNorm lookup 212446 Internal RxNorm lookup 226827 Internal RxNorm lookup 248656 Internal RxNorm lookup 308459 Internal RxNorm lookup 308460 Internal RxNorm lookup 749780 Internal RxNorm lookup 749783 Internal RxNorm lookup 750149 Internal RxNorm lookup 750157 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-4061-01 Zithromax 30 in 1 BOTTLE TABLET, FILM COATED 30 48 0069-4061-75 Zithromax 3 in 1 BOX TABLET, FILM COATED 3 48 0069-4061-75 Zithromax 6 in 1 BLISTER PACK TABLET, FILM COATED 6 48 0069-4061-89 Zithromax 1 in 1 BLISTER PACK TABLET, FILM COATED 1 48 0069-4061-89 Zithromax 50 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 50 48
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-4061 ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED ZITHROMAX (AZITHROMYCIN DIHYDRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 47 Current NDC, Legacy NDC, 5 package rows 20250205_db52b91e-79f7-4cc1-9564-f2eee8e31c45.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 Units Marketing start Marketing end Sample Exclude flag Status 0069-4061-01 00069406101 30 TABLET, FILM COATED in 1 BOTTLE (0069-4061-01) 2020-05-04 0000-00-00 No No Current 0069-4061-75 00069406175 3 in 1 BOX Historical 0069-4061-89 00069406189 50 BLISTER PACK in 1 BOX, UNIT-DOSE (0069-4061-89) > 1 TABLET, FILM COATED in 1 BLISTER PACK 50 blister pack 2019-07-18 0000-00-00 No No Current