Home NDC 63187-189 Azithromycin
Product NDC 63187-189
11-digit product format 631870189
Labeler code 63187
Product ID 63187-189_d6250595-3500-4c6f-8175-25a8a92e2d5e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA065223
Marketing category ANDA
Marketing start 2006-01-06
Substance AZITHROMYCIN MONOHYDRATE
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 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 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 63187-189 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63187-189 63187-189-03 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 A065223-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065223-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065223-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 MONOHYDRATE 500 mg/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248656 Internal RxNorm lookup 308460 Internal RxNorm lookup 749783 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 63187-189-03 Azithromycin 3 in 1 BLISTER PACK TABLET, FILM COATED 3 8 63187-189-03 Azithromycin 1 in 1 BOX TABLET, FILM COATED 1 8 63187-189-04 Azithromycin 4 in 1 BOTTLE TABLET, FILM COATED 4 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-189 AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 8 Current NDC, Legacy NDC, 3 package rows 20220927_7e7c2f49-449c-4ba2-98ae-0ff0c040614c.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 · 4 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 63187-189-03 63187018903 1 BLISTER PACK in 1 BOX (63187-189-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2014-10-01 0000-00-00 No No Current 63187-189-04 63187018904 4 TABLET, FILM COATED in 1 BOTTLE (63187-189-04) 2022-09-14 0000-00-00 No No Current