Erythromycin

Product NDC: 60760-670
11-digit product format: 607600670
Labeler code: 60760
Product ID: 60760-670_2cc7203b-1bf0-ccda-e063-6394a90ac207
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA064030
Marketing category: ANDA
Marketing start: 2023-10-18
Substance: ERYTHROMYCIN
Active strength: 5 mg/g
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A064030-001	ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1996-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064030-001	AT

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`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	A064030-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064030-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064030-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064030-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064030-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064030-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064030-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064030-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064030-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064030-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064030-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064030-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064030-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064030-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064030-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064030-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064030-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064030-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064030-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064030-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064030-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064030-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064030-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064030-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064030-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064030-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064030-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064030-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064030-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064030-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064030-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064030-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064030-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064030-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064030-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064030-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064030-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064030-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064030-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064030-001	AT	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	50c8d6b3-4660-e829-e063-6294a90a919b	2026-05-01	Adverse reactions	Exact identifier application applno (ANDA): 064030 application number: ANDA064030
Erythromycin	ERYTHROMYCIN	Sentiss Pharmaceuticals LLC	4da0e351-383f-55da-e063-6394a90a8eba	2026-03-31	Adverse reactions	Exact identifier application applno (ANDA): 064030 application number: ANDA064030
Erythromycin	ERYTHROMYCIN	Redpharm Drug	301ee5ad-3b6c-1152-e063-6294a90a54e7	2025-12-23	Adverse reactions	Exact identifier application applno (ANDA): 064030 application number: ANDA064030
Erythromycin	ERYTHROMYCIN	ST. MARY'S MEDICAL PARK PHARMACY	2cc726c2-3746-6dbf-e063-6294a90a789f	2025-01-28	Adverse reactions	Exact identifier application applno (ANDA): 064030 application number: ANDA064030 ndc (product): 60760-670
Erythromycin	ERYTHROMYCIN	ARMAS PHARMACEUTICALS INC.	07fdeac5-f690-d74b-e063-6394a90a5c5b	2023-10-23	Adverse reactions	Exact identifier application applno (ANDA): 064030 application number: ANDA064030
Erythromycin	ERYTHROMYCIN	Proficient Rx LP	62896bec-669e-4f20-a1e4-4f99afd35d32	2022-04-01	Adverse reactions	Exact identifier application applno (ANDA): 064030 application number: ANDA064030
Erythromycin	ERYTHROMYCIN	Asclemed USA, Inc.	bccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c	2022-03-07	Adverse reactions	Exact identifier application applno (ANDA): 064030 application number: ANDA064030

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERYTHROMYCIN	5 mg/g

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
310149	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
2cc726c2-3746-6dbf-e063-6294a90a789f	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
60760-670-35	Erythromycin	3.5 g in 1 TUBE	OINTMENT	3.5		1
60760-670-35	Erythromycin	1 in 1 CARTON	OINTMENT	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-670-35	GM - Gram	60760-670	f155603c-6a43-49b0-95c7-3e96a3484a92	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-670	ERYTHROMYCIN OINTMENT [ST. MARY'S MEDICAL PARK PHARMACY]	1	Current NDC, 2 package rows	20250206_2cc726c2-3746-6dbf-e063-6294a90a789f.zip

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
310149	erythromycin 0.5 % (5 MG/GM) Ophthalmic Ointment	PSN	2cc726c2-3746-6dbf-e063-6294a90a789f	1
310149	erythromycin 0.005 MG/MG Ophthalmic Ointment	SCD	2cc726c2-3746-6dbf-e063-6294a90a789f	1
310149	erythromycin 0.5 % Ophthalmic Ointment	SY	2cc726c2-3746-6dbf-e063-6294a90a789f	1
310149	erythromycin 5 MG per GM Ophthalmic Ointment	SY	2cc726c2-3746-6dbf-e063-6294a90a789f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60760-670-35	60760067035	1 TUBE in 1 CARTON (60760-670-35) / 3.5 g in 1 TUBE	1 tube	2025-01-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Ophthalmic Ointment USP, 0.5%	ST. MARY'S MEDICAL PARK PHARMACY	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	1