Home NDC 0069-3150 Zithromax
Product NDC 0069-3150
11-digit product format 000693150
Labeler code 0069
Product ID 0069-3150_b0eb7eb4-90fe-4add-a327-e8be68165a3b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azithromycin dihydrate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA050733
Marketing category NDA
Marketing start 1997-01-30
Substance AZITHROMYCIN DIHYDRATE
Active strength 500 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 42 .
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 N050733-001 ZITHROMAX AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION RLD 1997-01-30
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 · 42 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 2026-08-18 06:07:40 2026-07 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION RLD 1997-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 e64feba35796…
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 500 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1668238 Internal RxNorm lookup 1668240 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 0069-3150-83 Zithromax 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 40 0069-3150-84 Zithromax 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 40
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZITHROMYCIN DIHYDRATE ACTIVE INGREDIENT 5FD1131I7S ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 17 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 17 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 17 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-3150 ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 40 Current NDC, Legacy NDC, 2 package rows 20250221_3b631aa1-2d46-40bc-a614-d698301ea4f9.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 0069-3150-14 00069315014 10 VIAL in 1 CARTON (0069-3150-14) > 5 mL in 1 VIAL 10 vial 1997-01-30 0000-00-00 No No Current 0069-3150-83 00069315083 10 VIAL in 1 CARTON (0069-3150-83) / 5 mL in 1 VIAL (0069-3150-84) 10 vial 1997-01-30 0000-00-00 No No Current 0069-3150-84 00069315084 5 mL in 1 VIAL 5 ml Historical