Home NDC 70860-100 Azithromycin
Product NDC 70860-100
11-digit product format 708600100
Labeler code 70860
Product ID 70860-100_2cc930e3-dd57-6e2f-e063-6294a90a3111
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azithromycin monohydrate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Athenex Pharmaceutical Division, LLC.
Application ANDA065501
Marketing category ANDA
Marketing start 2017-01-01
Marketing end 2027-03-31
Substance AZITHROMYCIN MONOHYDRATE
Active strength 500 mg/5mL
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A065501-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065501-001 AP
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 · 43 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 2026-09-14 22:38:34 2026-08 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065501-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-11-09 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Azithromycin 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 70860-100-10 Azithromycin 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 13 70860-100-41 Azithromycin 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70860-100 AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.] 13 Current NDC, Legacy NDC, 2 package rows 20250130_324330c5-20fe-4b22-adf2-14a6e91e71ef.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 · 5 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 70860-100-10 70860010010 10 VIAL, SINGLE-DOSE in 1 CARTON (70860-100-10) / 5 mL in 1 VIAL, SINGLE-DOSE (70860-100-41) 2017-01-01 2027-03-31 No No Current 70860-100-41 70860010041 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical