Erythromycin Ethylsuccinate

Product NDC: 63629-2500
11-digit product format: 636292500
Labeler code: 63629
Product ID: 63629-2500_32c1c828-cd32-4b3e-8d73-9220e6650748
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin Ethylsuccinate
Dosage form: GRANULE, FOR SUSPENSION
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA050207
Marketing category: NDA
Marketing start: 2016-09-28
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-2500		D	Discontinued by firm		2026-08-03
excluded package	package	63629-2500	63629-2500-1	D	Discontinued by firm		2026-08-03

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
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 · 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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050207-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050207-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050207-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050207-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050207-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050207-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050207-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050207-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050207-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050207-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050207-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050207-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050207-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050207-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050207-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050207-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050207-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050207-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050207-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050207-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050207-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050207-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050207-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050207-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050207-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050207-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050207-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050207-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050207-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050207-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050207-001	AB	1	`79d66fd596c7…`
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…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2500	ERYTHROMYCIN ETHYLSUCCINATE GRANULE, FOR SUSPENSION [BRYANT RANCH PREPACK]	102	Legacy NDC	20240112_be467f06-daca-4a91-bd0f-85a5a62307c9.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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2500-1	63629250001	200 mL in 1 BOTTLE (63629-2500-1)	200 ml	2021-05-24	0000-00-00	No	No	Current