Erythromycin ethylsuccinate

Product NDC: 72162-2657
11-digit product format: 721622657
Labeler code: 72162
Product ID: 72162-2657_f39be42c-c032-403d-b271-6697c8b8bda6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin ethylsuccinate
Dosage form: FOR SUSPENSION
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA216212
Marketing category: ANDA
Marketing start: 2022-11-21
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2022-11-21
A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2022-11-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A216212-001	AB
A216212-002	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 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216212-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216212-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2022-11-21	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216212-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216212-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216212-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216212-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216212-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216212-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216212-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216212-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216212-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216212-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216212-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216212-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216212-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216212-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216212-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216212-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216212-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216212-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216212-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216212-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216212-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216212-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216212-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216212-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216212-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216212-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216212-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216212-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216212-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216212-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216212-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216212-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216212-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216212-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216212-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216212-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216212-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216212-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216212-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216212-002	AB	1	`a72a2bbeb626…`

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: 2027-12-31

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
1d9eb7cb-0b11-4f6e-8a9c-1bcff37fe0b5	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Bryant Ranch Prepack	78139f33-0965-4bbb-a53f-6d7fd4fa9a81	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216212 application number: ANDA216212
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Bryant Ranch Prepack	1d9eb7cb-0b11-4f6e-8a9c-1bcff37fe0b5	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216212 application number: ANDA216212 ndc (product): 72162-2657
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Kanchan Healthcare Inc	a7f7faaf-dc05-4d51-86c6-bf5d61562e48	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216212 application number: ANDA216212
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Nivagen Pharmaceuticals, Inc.	46f74c4f-10fc-44cf-aec4-d113f49149bc	2024-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216212 application number: ANDA216212
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Cadila Pharmaceuticals Limited	db70798e-5e07-41d6-afe9-82c272bc5cc0	2023-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216212 application number: ANDA216212

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	Sample	Exclude flag	Status
72162-2657-1	72162265701	100 mL in 1 BOTTLE (72162-2657-1)	100 ml	2026-06-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Ethylsuccinate for Oral Suspension,USP Rx only	Bryant Ranch Prepack	2026-06-05	HUMAN PRESCRIPTION DRUG LABEL	1