Erythromycin Ethylsuccinate

Product NDC: 52536-134
11-digit product format: 525360134
Labeler code: 52536
Product ID: 52536-134_98a85646-cc9b-429f-9b46-4a3ce1b5c129
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin Ethylsuccinate
Dosage form: GRANULE, FOR SUSPENSION
Route: ORAL
Labeler: Wilshire Pharmaceuticals Inc.
Application: NDA050207
Marketing category: NDA
Marketing start: 2016-09-28
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N050207-001	E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982
N050207-002	ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982
N050207-003	ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N050207-001	AB
N050207-002	AB
N050207-003	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 4 · 132 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	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050207-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050207-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050207-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050207-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050207-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050207-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050207-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050207-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050207-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050207-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050207-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050207-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050207-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050207-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050207-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050207-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050207-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050207-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050207-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050207-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050207-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050207-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050207-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050207-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050207-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050207-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050207-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050207-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050207-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050207-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050207-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050207-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050207-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050207-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050207-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050207-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050207-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050207-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050207-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050207-002	AB	1	`c0c555d07b60…`

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: 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f4a3fffd-ce02-450f-bbcc-d425374e3e32	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1ab	Product name	3	20250717
3b331500-3b74-bd2b-fede-d46839f2f4d5	Product name	6	20240313
fdae2630-eae0-4769-abfd-8f33d5b771b4	Product name	3	20240202
8c898317-b543-1e4e-254f-84cec2f3f57e	Product name	2	20191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebe	Product name	2	20180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9	Product name	2	20170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
57850177-5927-151f-e1fa-7e2ca47f81e5	Product name	1	20140508
8ee71591-1d8f-e24e-242b-bfef131e3168	Product name	1	20140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52536-134-13	Erythromycin Ethylsuccinate	100 mL in 1 BOTTLE	GRANULE, FOR SUSPENSION	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52536-134-13	ML - Milliliter	52536-134	4135fed9-dcc4-4552-93a6-c6ca845f770a	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52536-134	ERYTHROMYCIN ETHYLSUCCINATE GRANULE, FOR SUSPENSION [WILSHIRE PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 1 package rows	20190131_f4a3fffd-ce02-450f-bbcc-d425374e3e32.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
E.E.S 400	ERYTHROMYCIN ETHYLSUCCINATE	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	b455bbdb-a3f1-470f-aa5f-ed83ac2e228d	2023-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050207 application number: NDA050207
Ery-Ped	ERYTHROMYCIN ETHYLSUCCINATE	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	04775721-ab87-4b66-808c-d67a21032385	2023-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050207 application number: NDA050207
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	Wilshire Pharmaceuticals	86d6353c-2b58-4219-b31d-fb5b97789094	2020-09-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050207 application number: NDA050207
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Wilshire Pharmaceuticals Inc.	f4a3fffd-ce02-450f-bbcc-d425374e3e32	2019-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050207 application number: NDA050207 ndc (product): 52536-134

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1014KSJ86F	ERYTHROMYCIN ETHYLSUCCINATE	1264-62-6	ERYTHROMYCIN ETHYLSUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
686400	erythromycin ethylsuccinate 200 MG in 5 mL Oral Suspension	PSN	f4a3fffd-ce02-450f-bbcc-d425374e3e32	3
686400	erythromycin ethylsuccinate 40 MG/ML Oral Suspension	SCD	f4a3fffd-ce02-450f-bbcc-d425374e3e32	3
686400	EES 40 MG/ML Oral Suspension	SY	f4a3fffd-ce02-450f-bbcc-d425374e3e32	3
686400	erythromycin ethylsuccinate 200 MG per 5 ML Oral Suspension	SY	f4a3fffd-ce02-450f-bbcc-d425374e3e32	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52536-134-13	52536013413	100 mL in 1 BOTTLE (52536-134-13)	100 ml	2016-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ERYTHROMYCIN ETHYLSUCCINATE	Wilshire Pharmaceuticals Inc.	2019-01-29	HUMAN PRESCRIPTION DRUG LABEL	3