Home NDC 68788-8675 Azithromycin
Product NDC 68788-8675
11-digit product format 687888675
Labeler code 68788
Product ID 68788-8675_b24a545d-b889-455f-be44-e9d2b9215583
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA065246
Marketing category ANDA
Marketing start 2024-05-23
Substance AZITHROMYCIN MONOHYDRATE
Active strength 100 mg/5mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065246-001 AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 A065246-002 AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 86 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 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065246-001 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065246-002 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-05 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 100 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 308459 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 68788-8675-1 Azithromycin 15 mL in 1 BOTTLE POWDER, FOR SUSPENSION 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8675 AZITHROMYCIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] 2 Current NDC, 1 package rows 20250207_ac327054-21ab-401c-a27a-48259db18f89.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Azithromycin AZITHROMYCIN Preferred Pharmaceuticals Inc. ac327054-21ab-401c-a27a-48259db18f89 2026-03-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065246 application number: ANDA065246 ndc (product): 68788-8675 Azithromycin AZITHROMYCIN A-S Medication Solutions f97d2e7e-ccfd-4f04-85ba-549b37f6aa7b 2024-07-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065246 application number: ANDA065246 Azithromycin AZITHROMYCIN NuCare Pharmaceuticals,Inc. 549cdd0a-da79-23b8-e054-00144ff8d46c 2024-07-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065246 application number: ANDA065246 Azithromycin AZITHROMYCIN Proficient Rx LP 44134421-cb0b-4e85-a3c8-d58bdb476fad 2024-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 065246 application number: ANDA065246 Azithromycin AZITHROMYCIN STATE HEALTH SERVICES, TEXAS DEPARTMENT OF 2b821631-0df2-0fb2-e054-00144ff8d46c 2024-02-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065246 application number: ANDA065246
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8675-1 68788867501 15 mL in 1 BOTTLE (68788-8675-1) 15 ml 2024-05-23 No No Current