Home NDC 62332-252 Azithromycin
Product NDC 62332-252
11-digit product format 623320252
Labeler code 62332
Product ID 62332-252_07166b55-b3f9-4c2d-a21b-122fa209fb72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA211792
Marketing category ANDA
Marketing start 2020-01-29
Substance AZITHROMYCIN DIHYDRATE
Active strength 500 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A211792-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211792-001 AB
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.
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 2026-10-15 13:18:30 2026-09 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211792-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2020-01-28 a50c72e98297…
Observed Orange Book normalized TE history# 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZITHROMYCIN DIHYDRATE 500 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62332-252-03 Azithromycin 3 in 1 BLISTER PACK TABLET, FILM COATED 3 12 62332-252-03 Azithromycin 3 in 1 CARTON TABLET, FILM COATED 3 12 62332-252-09 Azithromycin 3 in 1 CARTON TABLET, FILM COATED 3 12 62332-252-09 Azithromycin 3 in 1 BLISTER PACK TABLET, FILM COATED 3 12 62332-252-30 Azithromycin 30 in 1 BOTTLE TABLET, FILM COATED 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-252 AZITHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] 12 Current NDC, Legacy NDC, 5 package rows 20220301_45410338-6bff-476b-b8e1-6c6238205a99.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 · 3 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 62332-252-03 62332025203 3 BLISTER PACK in 1 CARTON (62332-252-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2020-01-29 0000-00-00 No No Current 62332-252-09 62332025209 3 BLISTER PACK in 1 CARTON (62332-252-09) / 3 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2020-01-29 0000-00-00 No No Current 62332-252-30 62332025230 30 TABLET, FILM COATED in 1 BOTTLE (62332-252-30) 2020-01-29 0000-00-00 No No Current