Erythromycin

Product NDC: 69238-1472
11-digit product format: 692381472
Labeler code: 69238
Product ID: 69238-1472_ecd62575-1fd6-4ed0-ba18-048be51a607c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA210954
Marketing category: ANDA
Marketing start: 2019-07-07
Substance: ERYTHROMYCIN
Active strength: 333 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

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	Approval date
A210954-001	ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02
A210954-002	ERYTHROMYCIN	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02
A210954-003	ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210954-001	AB
A210954-002	AB
A210954-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`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	A210954-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210954-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210954-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210954-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210954-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210954-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210954-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210954-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210954-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210954-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Erythromycin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERYTHROMYCIN	333 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310155	Internal RxNorm lookup
310157	Internal RxNorm lookup
315090	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
bb641ed4-8093-4e15-9cb9-8921b1093d50	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
69238-1472-1	Erythromycin	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100		10
69238-1472-3	Erythromycin	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1472-1	EA - Each	69238-1472	af6ef92b-c3c0-4b52-9645-cae36a48eefa	1	2019-08-06
69238-1472-3	EA - Each	69238-1472	5da57632-3338-4752-9f10-10936ced2d21	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1472	ERYTHROMYCIN TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]	10	Current NDC, Legacy NDC, 2 package rows	20241219_bb641ed4-8093-4e15-9cb9-8921b1093d50.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	Amneal Pharmaceuticals NY LLC	bb641ed4-8093-4e15-9cb9-8921b1093d50	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210954 application number: ANDA210954 ndc (product): 69238-1472

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
310155	erythromycin 250 MG Delayed Release Oral Tablet	PSN	bb641ed4-8093-4e15-9cb9-8921b1093d50	10
315090	erythromycin 333 MG Delayed Release Oral Tablet	PSN	bb641ed4-8093-4e15-9cb9-8921b1093d50	10
310157	erythromycin 500 MG Delayed Release Oral Tablet	PSN	bb641ed4-8093-4e15-9cb9-8921b1093d50	10
310155	erythromycin 250 MG Delayed Release Oral Tablet	SCD	bb641ed4-8093-4e15-9cb9-8921b1093d50	10
315090	erythromycin 333 MG Delayed Release Oral Tablet	SCD	bb641ed4-8093-4e15-9cb9-8921b1093d50	10
310157	erythromycin 500 MG Delayed Release Oral Tablet	SCD	bb641ed4-8093-4e15-9cb9-8921b1093d50	10
315090	erythromycin 333 MG Delayed Release Oral Tablet	PSN	29a56565-4a92-4626-9567-5592d661a896	2
315090	erythromycin 333 MG Delayed Release Oral Tablet	SCD	29a56565-4a92-4626-9567-5592d661a896	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1472-1	69238147201	100 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1472-1)	2019-07-07	0000-00-00	No	No	Current
69238-1472-3	69238147203	30 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1472-3)	2021-08-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Delayed-Release Tablets, USP (250 mg, 333 mg and 500 mg) Rx only	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals Private Limited	2024-12-10	HUMAN PRESCRIPTION DRUG LABEL	10
Erythromycin Delayed-Release Tablets, USP (250 mg, 333 mg and 500 mg) Rx only	A-S Medication Solutions	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	2