Home NDC 62559-440 Erythromycin Ethylsuccinate
Product NDC 62559-440
11-digit product format 625590440
Labeler code 62559
Product ID 62559-440_f11e2e76-7778-4d82-961d-a16dd2bc84ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Erythromycin Ethylsuccinate
Dosage form GRANULE, FOR SUSPENSION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA062055
Marketing category ANDA
Marketing start 2016-09-27
Substance ERYTHROMYCIN ETHYLSUCCINATE
Active strength 200 mg/5mL
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062055-001 ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062055-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2018-11-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062055-003 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2018-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062055-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB Approved before 1982 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Erythromycin Ethylsuccinate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014KSJ86F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 686400 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 62559-440-01 Erythromycin Ethylsuccinate 100 mL in 1 BOTTLE GRANULE, FOR SUSPENSION 100 10 62559-440-02 Erythromycin Ethylsuccinate 200 mL in 1 BOTTLE GRANULE, FOR SUSPENSION 200 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-440 ERYTHROMYCIN ETHYLSUCCINATE GRANULE, FOR SUSPENSION [ANI PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20231220_3de1e0b9-473b-44c0-a644-5fa14ad69a83.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 · 2 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 62559-440-01 62559044001 100 mL in 1 BOTTLE (62559-440-01) 100 ml 2016-09-27 0000-00-00 No No Current 62559-440-02 62559044002 200 mL in 1 BOTTLE (62559-440-02) 200 ml 2016-09-27 0000-00-00 No No Current