Application 064067

Type: ANDA
Sponsor: BAUSCH AND LOMB

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 42.

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
A064067-001	ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064067-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A064067-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064067-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064067-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064067-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064067-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064067-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064067-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064067-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064067-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064067-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064067-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064067-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064067-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064067-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064067-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064067-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064067-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064067-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064067-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064067-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064067-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064067-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064067-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064067-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064067-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064067-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064067-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064067-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064067-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064067-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064067-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064067-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064067-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064067-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064067-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064067-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064067-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064067-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064067-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064067-001	AT	1	`e64feba35796…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin	ERYTHROMYCIN	Sportpharm LLC	790d3e3e-df69-45f7-97d5-da65faa46556	2026-07-21	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067
Erythromycin	ERYTHROMYCIN	Cardinal Health 107, LLC	ba4f06c3-ebce-4896-a5cc-59bb5c2cb4e5	2026-04-27	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 55154-7850
Erythromycin	ERYTHROMYCIN	Preferred Pharmaceuticals, Inc.	ee3d806e-65ce-42e1-b170-7b35bcb7b06a	2026-04-10	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 68788-9328
ERYTHROMYCIN	ERYTHROMYCIN	Direct Rx	9ac4dcd2-8cac-404d-b651-da74062d30ed	2026-03-17	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 61919-090
Erythromycin	ERYTHROMYCIN	REMEDYREPACK INC.	c49ad63b-c2fd-4535-bec0-6415c93cf847	2026-01-09	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 70518-0465
Erythromycin	ERYTHROMYCIN	A-S Medication Solutions	2be16639-b153-407b-b43d-3a2bcf66151e	2025-12-03	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 50090-1484
Erythromycin	ERYTHROMYCIN	Bausch & Lomb Incorporated	061ddd20-94a6-4e3c-ba84-1ebd8529eea6	2025-04-22	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 24208-910
Erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	5568ade8-bdc2-1a32-e054-00144ff8d46c	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 66267-975
Erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	6296e2ed-334c-b9af-e053-2991aa0aae0c	2024-06-06	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 68071-4228
Erythromycin	ERYTHROMYCIN	Proficient Rx LP	5101bf55-cacf-42bf-8dd1-2a29e80ca6f1	2022-07-01	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 63187-608
Erythromycin	ERYTHROMYCIN	Asclemed USA, Inc.	7810e881-5130-4a94-b2e0-9f63f8a7a504	2021-11-30	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 76420-196

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-173	Erythromycin	Erythromycin	Rebel Distributors Corp	ANDA	Current
24208-910	Erythromycin	Erythromycin	Bausch & Lomb Incorporated	ANDA	Current
24208-910	Erythromycin	Erythromycin	Bausch & Lomb Incorporated	ANDA	Current
24208-910	Erythromycin	Erythromycin	Bausch & Lomb Incorporated	ANDA	Current
50090-1484	Erythromycin	Erythromycin	A-S Medication Solutions	ANDA	Current
50090-1484	Erythromycin	Erythromycin	A-S Medication Solutions	ANDA	Current
50090-1484	Erythromycin	Erythromycin	A-S Medication Solutions	ANDA	Current
52959-301	Erythromycin	Erythromycin	H.J. Harkins Company, Inc.	ANDA	Current
53002-9050	Erythromycin	Erythromycin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9050	Erythromycin	Erythromycin	RPK Pharmaceuticals, Inc.	ANDA	Current
55154-7850	Erythromycin	Erythromycin	Cardinal Health	ANDA	Current
55154-7850	Erythromycin	Erythromycin	Cardinal Health 107, LLC	ANDA	Current
55700-478	Erythromycin	Erythromycin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-090	ERYTHROMYCIN	ERYTHROMYCIN	Direct Rx	ANDA	Current
61919-090	ERYTHROMYCIN	ERYTHROMYCIN	Direct Rx	ANDA	Current
63187-608	Erythromycin	Erythromycin	Proficient Rx LP	ANDA	Current
63187-608	Erythromycin	Erythromycin	Proficient Rx LP	ANDA	Current
63187-608	Erythromycin	Erythromycin	Proficient Rx LP	ANDA	Current
63187-608	Erythromycin	Erythromycin	Proficient Rx LP	ANDA	Current
66267-975	Erythromycin	Erythromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-975	Erythromycin	Erythromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-975	Erythromycin	Erythromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4228	Erythromycin	Erythromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4228	Erythromycin	Erythromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9328	Erythromycin	Erythromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9328	Erythromycin	Erythromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9328	Erythromycin	Erythromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9328	Erythromycin	Erythromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9328	Erythromycin	Erythromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0465	Erythromycin	Erythromycin	REMEDYREPACK INC.	ANDA	Current
70518-0465	Erythromycin	Erythromycin	REMEDYREPACK INC.	ANDA	Current
70518-0465	Erythromycin	Erythromycin	REMEDYREPACK INC.	ANDA	Current
70518-0465	Erythromycin	Erythromycin	REMEDYREPACK INC.	ANDA	Current
70518-0465	Erythromycin	Erythromycin	REMEDYREPACK INC.	ANDA	Current
70518-0465	Erythromycin	Erythromycin	REMEDYREPACK INC.	ANDA	Current
76413-106	Erythromycin	Erythromycin	Central Texas Community Health Centers	ANDA	Current
76420-196	Erythromycin	Erythromycin	Asclemed USA, Inc.	ANDA	Current