ERYTHROMYCIN

Product NDC: 75834-243
Requested package NDC: 75834-243-30
11-digit product format: 758340243
Labeler code: 75834
Product ID: 75834-243_e40dea9d-181d-4775-8912-ac1fc0d84b23
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ERYTHROMYCIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA213628
Marketing category: ANDA
Marketing start: 2021-07-15
Substance: ERYTHROMYCIN
Active strength: 500 mg/1
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	75834-243	75834-243-30	D	Discontinued by firm		2026-09-14

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
A213628-001	ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28
A213628-002	ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213628-001	AB
A213628-002	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 · 70 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
2026-09-14 22:38:34	2026-08	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB		2021-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB		2021-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB		2021-06-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB		2021-06-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A213628-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213628-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213628-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213628-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213628-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213628-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213628-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213628-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213628-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213628-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213628-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213628-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213628-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213628-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213628-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213628-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213628-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213628-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213628-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213628-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213628-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213628-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213628-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213628-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213628-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213628-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213628-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213628-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213628-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213628-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213628-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213628-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213628-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213628-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213628-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213628-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213628-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213628-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213628-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213628-002	AB	1	`bb7c543d1eb4…`

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
75834-243-01	ERYTHROMYCIN	100 in 1 BOTTLE	TABLET, FILM COATED	100		2
75834-243-30	ERYTHROMYCIN	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-243-01	EA - Each	75834-243	3170bb9a-526e-4eea-a8d4-18a6c2c6f9c9	1	2021-09-07
75834-243-30	EA - Each	75834-243	4956f285-7f0f-4a69-a257-56dbc83dfa73	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-243	ERYTHROMYCIN TABLET, FILM COATED [NIVAGEN PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20240117_aa61cb37-5fc5-4225-b894-1d660386777f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin	ERYTHROMYCIN	Modavar Pharmaceuticals LLC	bc3d091b-1fc8-4f7a-a3c2-8ede87f5faa0	2023-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213628 application number: ANDA213628
Erythromycin	ERYTHROMYCIN	Cadila Pharmaceuticals Limited	fae8fc38-3c60-43b8-a0f9-2c50df332505	2023-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213628 application number: ANDA213628
Erythromycin	ERYTHROMYCIN	Orange Pharmaceuticals USA LLC	379ed8f7-b54f-495f-932e-cd0e4c691134	2021-07-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213628 application number: ANDA213628

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
63937KV33D	ERYTHROMYCIN	114-07-8	ERYTHROMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
598006	erythromycin 250 MG Oral Tablet	PSN	aa61cb37-5fc5-4225-b894-1d660386777f	2
197650	erythromycin 500 MG Oral Tablet	PSN	aa61cb37-5fc5-4225-b894-1d660386777f	2
598006	erythromycin 250 MG Oral Tablet	SCD	aa61cb37-5fc5-4225-b894-1d660386777f	2
197650	erythromycin 500 MG Oral Tablet	SCD	aa61cb37-5fc5-4225-b894-1d660386777f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-243-30	75834024330	30 TABLET, FILM COATED in 1 BOTTLE (75834-243-30)	2021-07-15	0000-00-00	No	No	Current