Home NDC 63323-398-12 Azithromycin
Product NDC 63323-398
Requested package NDC 63323-398-12
11-digit product format 633230398
Labeler code 63323
Product ID 63323-398_2143a7d1-6575-4d24-8ef4-001ecf2671e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AZITHROMYCIN MONOHYDRATE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA065179
Marketing category ANDA
Marketing start 2006-03-20
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 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 A065179-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065179-001 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 · 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 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065179-001 AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2005-12-13 cb3db0bc1861…
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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-398-01 Azithromycin 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 8 63323-398-10 Azithromycin 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 8 63323-398-14 Azithromycin 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 4 63323-398-41 Azithromycin 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 6 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 6 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 6 AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-398 AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20241018_b69917c0-95d5-4b29-b0e3-07054a4fd79f.zip 63323-398 AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241018_9ad099d5-5c57-4855-98a4-e03fb4629dbf.zip 63323-398 AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC 20241018_62f6f327-3fef-49f0-ae90-078356d002b5.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 63323-398-12 63323039812 10 VIAL in 1 TRAY (63323-398-12) > 5 mL in 1 VIAL 10 vial 2006-03-20 0000-00-00 No No Current