erythromycin

Product NDC: 75907-076
11-digit product format: 759070076
Labeler code: 75907
Product ID: 75907-076_3657e1bd-fd4f-ba88-c3af-bddb79a2e594
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: erythromycin
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Dr. Reddy's Labratories Inc.
Application: NDA050536
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-09-01
Marketing end: 2027-02-28
Substance: ERYTHROMYCIN
Active strength: 250 mg/1
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag: No
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050536-001	ERYC	ERYTHROMYCIN	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050536-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050536-001	ERYC	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N050536-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050536-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050536-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050536-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050536-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050536-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050536-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050536-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050536-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050536-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050536-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050536-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050536-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050536-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050536-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050536-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050536-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050536-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050536-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050536-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050536-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050536-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050536-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050536-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050536-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050536-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050536-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050536-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050536-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050536-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050536-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050536-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050536-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050536-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050536-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050536-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050536-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050536-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050536-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050536-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: erythromycin

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERYTHROMYCIN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
63937KV33D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310154	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
a2dcb48a-212c-1b0c-ec35-ee2ade85847f	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
75907-076-01	erythromycin	100 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE PELLETS	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75907-076-01	EA - Each	75907-076	2e2e191d-8041-4671-8130-9cba3f8be213	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75907-076	ERYTHROMYCIN CAPSULE, DELAYED RELEASE PELLETS [DR. REDDY'S LABRATORIES INC.]	1	Current NDC, 1 package rows	20240901_a2dcb48a-212c-1b0c-ec35-ee2ade85847f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
erythromycin	ERYTHROMYCIN	Dr. Reddy's Labratories Inc.	a2dcb48a-212c-1b0c-ec35-ee2ade85847f	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050536 application number: NDA050536 ndc (product): 75907-076

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
310154	erythromycin 250 MG Delayed Release Oral Capsule	PSN	a2dcb48a-212c-1b0c-ec35-ee2ade85847f	2
310154	erythromycin 250 MG Delayed Release Oral Capsule	SCD	a2dcb48a-212c-1b0c-ec35-ee2ade85847f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
75907-076-01	75907007601	100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (75907-076-01)	2024-09-01	2027-02-28	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Delayed-Release Capsules, USP	Dr. Reddy's Labratories Inc.	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	2