Erythromycin

Product NDC: 68071-5279
11-digit product format: 680715279
Labeler code: 68071
Product ID: 68071-5279_d77077d1-83cc-f00b-e053-2995a90aec2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA064030
Marketing category: ANDA
Marketing start: 1996-07-18
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-5279		D	Discontinued by firm		2026-08-10
excluded package	package	68071-5279	68071-5279-3	D	Discontinued by firm		2026-08-10

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5279-3	2022-02-07	C162847	48780-1	d6a99b39-4096-a426-e053-dadaa90af4c2	Erythromycin Ophthalmic Ointment USP, 0.5%
68071-5279-3	2022-01-28	C162847	48780-1	d6a99b39-4096-a426-e053-dadaa90af4c2	Erythromycin Ophthalmic Ointment USP, 0.5%

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5279	ERYTHROMYCIN OINTMENT [NUCARE PHARMACEUTICALS,INC.]	5	Legacy NDC	20250126_a7d15f71-3050-5452-e053-2a95a90a1d4e.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 · 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
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5279-3	68071527903	3.5 g in 1 BOX (68071-5279-3)	3.5 g	2020-06-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Ophthalmic Ointment USP, 0.5%	NuCare Pharmaceuticals,Inc.	2025-01-24	HUMAN PRESCRIPTION DRUG LABEL	5