Application 064030

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYTHROMYCIN	ERYTHROMYCIN	OINTMENT;OPHTHALMIC	0.5%	No	No

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#

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 ndc (product): 63187-267
Erythromycin	ERYTHROMYCIN	Asclemed USA, Inc.	bccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c	2022-03-07	Adverse reactions	Exact identifier application applno (ANDA): 064030 application number: ANDA064030 ndc (product): 76420-212

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-7191	Erythromycin	Erythromycin	Henry Schein Inc.	ANDA	Current
0404-7191	Erythromycin	Erythromycin	Henry Schein Inc.	ANDA	Current
0404-7191	Erythromycin	Erythromycin	Henry Schein Inc.	ANDA	Current
13985-605	Erythromycin	Erythromycin	MWI	ANDA	Current
13985-605	Erythromycin	Erythromycin	MWI	ANDA	Current
13985-605	Erythromycin	Erythromycin	MWI	ANDA	Current
17478-070	Erythromycin	Erythromycin	Akorn, Inc.	ANDA	Current
17478-070	Erythromycin	Erythromycin	Akorn	ANDA	Current
17478-070	Erythromycin	Erythromycin	Akorn, Inc.	ANDA	Current
17478-070	Erythromycin	Erythromycin	Akorn	ANDA	Current
17478-824	Erythromycin	Erythromycin	Akorn, Inc.	ANDA	Current
17478-824	Erythromycin	Erythromycin	Akorn, Inc.	ANDA	Current
50090-0248	Erythromycin	Erythromycin	A-S Medication Solutions	ANDA	Current
50090-0248	Erythromycin	Erythromycin	A-S Medication Solutions	ANDA	Current
50090-0248	Erythromycin	Erythromycin	A-S Medication Solutions	ANDA	Current
55045-1350	Erythromycin	Erythromycin	Dispensing Solutions, Inc.	ANDA	Current
55154-1276	Erythromycin	Erythromycin	Cardinal Health	ANDA	Current
55700-151	Erythromycin	Erythromycin	Lake Erie Medical DBA Quality Caer Products LLC	ANDA	Current
63187-267	Erythromycin	Erythromycin	Proficient Rx LP	ANDA	Current
63187-267	Erythromycin	Erythromycin	Proficient Rx LP	ANDA	Current
63187-267	Erythromycin	Erythromycin	Proficient Rx LP	ANDA	Current
68071-5279	Erythromycin	Erythromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5279	Erythromycin	Erythromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9203	Erythromycin	Erythromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0138	Erythromycin	Erythromycin	REMEDYREPACK INC.	ANDA	Current
70518-0138	Erythromycin	Erythromycin	REMEDYREPACK INC.	ANDA	Current
76420-212	Erythromycin	Erythromycin	Asclemed USA, Inc.	ANDA	Current