Home NDC 62756-512 Azithromycin
Product NDC 62756-512
11-digit product format 627560512
Labeler code 62756
Product ID 62756-512_822e078d-ea93-4a4b-b640-2cc7174f5b52
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA090923
Marketing category ANDA
Marketing start 2020-07-15
Substance AZITHROMYCIN MONOHYDRATE
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 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 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 62756-512 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 62756-512 62756-512-44 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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 A090923-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02
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 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2013-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090923-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2013-04-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Azithromycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZITHROMYCIN MONOHYDRATE 500 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JTE4MNN1MD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1668238 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 62756-512-40 Azithromycin 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 19 62756-512-44 Azithromycin 10 in 1 PACKAGE INJECTION, POWDER, LYOPHILIZED, 10 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 8 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 8 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 8 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-512 AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20200715_6a22beb6-57e8-480d-97b5-44d9dbfabf93.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.
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 62756-512-40 62756051240 5 mL in 1 VIAL 5 ml Historical 62756-512-44 62756051244 10 VIAL in 1 PACKAGE (62756-512-44) / 5 mL in 1 VIAL (62756-512-40) 10 vial 2020-07-15 0000-00-00 No No Current