Home NDC 21695-549 Azithromycin
Product NDC 21695-549
11-digit product format 216950549
Labeler code 21695
Product ID 21695-549_72cd7af3-24c4-4a06-b079-ba47d07d7253
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin monohydrate
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Rebel Distributors Corp.
Application ANDA065419
Marketing category ANDA
Marketing start 2008-06-24
Marketing end 0000-00-00
Substance AZITHROMYCIN MONOHYDRATE
Active strength 200 mg/5mL
Pharmacologic classes Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A065419-001 AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 A065419-002 AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24
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 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-06-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-06-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065419-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065419-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2008-06-24 782e0a99824c…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21695-549-15 Azithromycin 15 mL in 1 BOTTLE POWDER, FOR SUSPENSION 15 2 21695-549-22 Azithromycin 22.5 mL in 1 BOTTLE POWDER, FOR SUSPENSION 22.5 2 21695-549-30 Azithromycin 30 mL in 1 BOTTLE POWDER, FOR SUSPENSION 30 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded azithromycin monohydrate ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] 2 azithromycin ACTIVE MOIETY F94OW58Y8V AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] 2 ethyl vanillin INACTIVE INGREDIENT YC9ST449YJ AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] 2 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] 2 SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE INACTIVE INGREDIENT B70850QPHR AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] 2 sucrose INACTIVE INGREDIENT C151H8M554 AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] 2 vanillin INACTIVE INGREDIENT CHI530446X AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-549 AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] 2 Legacy NDC, 3 package rows 20111021_58b72e4c-f419-4a70-b894-93a5804d9993.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 21695-549-15 21695054915 15 mL in 1 BOTTLE 15 ml Historical 21695-549-22 21695054922 22.5 mL in 1 BOTTLE 22.5 ml Historical 21695-549-30 21695054930 30 mL in 1 BOTTLE 30 ml Historical