Home NDC 59762-3130 azithromycin
Product NDC 59762-3130
11-digit product format 597623130
Labeler code 59762
Product ID 59762-3130_86aefdeb-2e61-4763-8593-fce5f69f5564
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azithromycin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Greenstone LLC
Application NDA050710
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1995-10-19
Marketing end 0000-00-00
Substance AZITHROMYCIN DIHYDRATE
Active strength 900 mg/22.5mL
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 59762-3130 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59762-3130 59762-3130-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 N050710-001 ZITHROMAX AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 N050710-002 ZITHROMAX AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19
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 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZITHROMYCIN DIHYDRATE ACTIVE INGREDIENT 5FD1131I7S AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 LACTOSE INACTIVE INGREDIENT J2B2A4N98G AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS INACTIVE INGREDIENT SX01TZO3QZ AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 SUCROSE INACTIVE INGREDIENT C151H8M554 AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-3130 AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC] 41 Legacy NDC 20250416_f5b6daad-b5a9-462d-8e10-db22a7af1c72.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zithromax AZITHROMYCIN DIHYDRATE Pfizer Laboratories Div Pfizer Inc db52b91e-79f7-4cc1-9564-f2eee8e31c45 2026-07-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 050710 application number: NDA050710
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 59762-3130-1 59762313001 1 BOTTLE in 1 CARTON (59762-3130-1) > 22.5 mL in 1 BOTTLE 1 bottle 1995-10-19 0000-00-00 No No Current