Home NDC 11788-128 Azithromycin
Product NDC 11788-128
11-digit product format 117880128
Labeler code 11788
Product ID 11788-128_b4d8ea81-97cd-4aeb-a1a9-48e3f8587356
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler AiPing Pharmaceutical, Inc.
Application ANDA217036
Marketing category ANDA
Marketing start 2026-01-16
Substance AZITHROMYCIN DIHYDRATE
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 42 .
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 A217036-001 AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 A217036-002 AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217036-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217036-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-07-27 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Azithromycin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZITHROMYCIN DIHYDRATE 100 mg/5mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 141963 Internal RxNorm lookup 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 11788-128-13 Azithromycin 1 in 1 CARTON POWDER, FOR SUSPENSION 1 1 11788-128-13 Azithromycin 15 mL in 1 BOTTLE POWDER, FOR SUSPENSION 15 1
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 Sample Exclude flag Status 11788-128-13 11788012813 1 BOTTLE in 1 CARTON (11788-128-13) / 15 mL in 1 BOTTLE 1 bottle 2026-01-16 No No Current