Home NDC 0069-3140 Zithromax
Product NDC 0069-3140
11-digit product format 000693140
Labeler code 0069
Product ID 0069-3140_e15f2173-8700-4392-96a4-8560772b6f8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azithromycin dihydrate
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA050710
Marketing category NDA
Marketing start 1995-10-19
Substance AZITHROMYCIN DIHYDRATE
Active strength 200 mg/5mL
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Zithromax
Listing expiration 2027-12-31 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 · 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 0069-3140-19 Zithromax 1 in 1 CARTON POWDER, FOR SUSPENSION 1 48 0069-3140-19 Zithromax 30 mL in 1 BOTTLE POWDER, FOR SUSPENSION 30 48
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-3140 ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED ZITHROMAX (AZITHROMYCIN DIHYDRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 47 Current NDC, Legacy NDC, 2 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 · 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 ndc (product): 0069-3140
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 0069-3140-19 00069314019 1 BOTTLE in 1 CARTON (0069-3140-19) / 30 mL in 1 BOTTLE 1 bottle 1995-10-19 0000-00-00 No No Current