Application 064068

Type: ANDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	OINTMENT;OPHTHALMIC	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	No	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
A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064068-001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064068-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064068-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064068-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064068-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064068-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064068-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064068-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064068-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064068-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064068-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064068-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064068-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064068-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A064068-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064068-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064068-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064068-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064068-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone	NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE	Bausch & Lomb Incorporated	3b00eb5c-dd98-467e-a883-04c37a8ecc42	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064068 application number: ANDA064068 ndc (product): 24208-785

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11695-1406	NEO-POLY-BAC HYDRO	Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	Butler Animal Health Supply	ANDA	Current
13985-016	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone	Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	MWI/VetOne	ANDA	Current
13985-745	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone	Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	MWI	ANDA	Current
24208-785	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone	Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	Bausch & Lomb Incorporated	ANDA	Current
24208-785	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone	Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	Bausch & Lomb Incorporated	ANDA	Current
24208-785	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone	Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	Bausch & Lomb Incorporated	ANDA	Current
24208-785	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone	Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	Bausch & Lomb Incorporated	ANDA	Current
57319-344	Triple Antibiotic HC	Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	Phoenix Pharmaceutical, Inc.	ANDA	Current