Home NDC 64980-727 azithromycin
Product NDC 64980-727
11-digit product format 649800727
Labeler code 64980
Product ID 64980-727_519978dd-d9ba-b047-e063-6394a90aff16
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AZITHROMYCIN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA209045
Marketing category ANDA
Marketing start 2026-06-03
Substance AZITHROMYCIN DIHYDRATE
Active strength 250 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 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 A209045-001 AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209045-001 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.
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 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209045-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2018-12-07 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZITHROMYCIN DIHYDRATE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5FD1131I7S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248656 Internal RxNorm lookup 308460 Internal RxNorm lookup 749780 Internal RxNorm lookup 749783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 64980-727-03 64980072703 30 TABLET, FILM COATED in 1 BOTTLE (64980-727-03) 2026-06-03 No No Current 64980-727-16 64980072716 6 TABLET, FILM COATED in 1 BLISTER PACK (64980-727-16) 2026-06-03 No No Current