Home NDC 60219-1504 Erythromycin Ethylsuccinate
Product NDC 60219-1504
11-digit product format 602191504
Labeler code 60219
Product ID 60219-1504_0488543c-588b-4b75-acb3-4999aa84ebfc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Erythromycin
Dosage form SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA211204
Marketing category ANDA
Marketing start 2023-12-02
Substance ERYTHROMYCIN ETHYLSUCCINATE
Active strength 400 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01
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 · 78 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 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211204-001 ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE / ORAL AB 2019-11-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211204-002 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE / ORAL AB 2019-11-01 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 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 400 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 686400 Internal RxNorm lookup 686418 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 60219-1504-2 Erythromycin Ethylsuccinate 100 mL in 1 BOTTLE SUSPENSION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-1504 ERYTHROMYCIN ETHYLSUCCINATE (ERYTHROMYCIN) SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC] 2 Current NDC, 1 package rows 20250427_581d7430-1a80-42a6-befb-4c3ae8140392.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 Sample Exclude flag Status 60219-1504-2 60219150402 100 mL in 1 BOTTLE (60219-1504-2) 100 ml 2023-12-02 No No Current