Bacitracin Zinc and Polymyxin B Sulfate

Product NDC: 0168-0273
11-digit product format: 001680273
Labeler code: 0168
Product ID: 0168-0273_e16cc886-1989-4220-85ae-6b0cc2e3dee4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bacitracin Zinc and Polymyxin B Sulfate
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: E. FOUGERA & CO., A division of Nycomed US Inc.
Application: ANDA065022
Marketing category: ANDA
Marketing start: 2008-08-28
Marketing end: 0000-00-00
Substance: BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength: 500 1/g; 1/g
Pharmacologic classes: Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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	0168-0273		I	Inactivated by FDA		2026-08-10
excluded package	package	0168-0273	0168-0273-38	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0168-0273-38	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0168-0273-38	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0168-0273-38	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0168-0273-38	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0168-0273-38	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0168-0273-38	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0168-0273-38	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0168-0273-38	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0168-0273-38	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0168-0273-38	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0168-0273-38	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0168-0273-38	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0168-0273-38	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0168-0273-38	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0168-0273-38	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0168-0273-38	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0168-0273-38	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0168-0273-38	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0168-0273-38	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0168-0273-38	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0168-0273-38	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0168-0273-38	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	BACITRACIN ZINC; POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC			2002-02-27

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	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065022-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065022-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065022-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065022-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065022-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065022-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065022-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065022-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065022-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065022-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065022-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065022-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065022-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065022-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065022-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065022-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065022-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065022-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065022-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065022-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065022-001	AT	1	`87673890dc5c…`
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2020-11-12 02:37 UTC	2020-11	A065022-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065022-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065022-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065022-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065022-001	AT	1	`6a51e52b5d6a…`
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DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0168-0273-38	2020-01-31	C162847	48780-1	9d75b9d0-0574-f424-e053-dadaa90a57ce	BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINTMENT, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0168-0273-38	Bacitracin Zinc and Polymyxin B Sulfate	3.5 g in 1 TUBE	OINTMENT	3.5		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Bacitracin Zinc	ACTIVE INGREDIENT	89Y4M234ES	BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [E. FOUGERA & CO., A DIVISION OF NYCOMED US INC.]	4
polymyxin B sulfate	ACTIVE INGREDIENT	19371312D4	BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [E. FOUGERA & CO., A DIVISION OF NYCOMED US INC.]	4
bacitracin	ACTIVE MOIETY	58H6RWO52I	BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [E. FOUGERA & CO., A DIVISION OF NYCOMED US INC.]	4
polymyxin B	ACTIVE MOIETY	J2VZ07J96K	BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [E. FOUGERA & CO., A DIVISION OF NYCOMED US INC.]	4
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [E. FOUGERA & CO., A DIVISION OF NYCOMED US INC.]	4
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [E. FOUGERA & CO., A DIVISION OF NYCOMED US INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0168-0273	BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [E. FOUGERA & CO., A DIVISION OF NYCOMED US INC.]	4	Legacy NDC, 1 package rows	20090923_58f12018-ef71-4a2b-a6f5-6ec3ac19c353.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
polycin	BACITRACIN ZINC AND POLYMYXIN B SULFATES	NuCare Pharmaceuticals,Inc.	5d55e918-98a0-4989-e053-2a91aa0a9ad7	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065022 application number: ANDA065022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308511	bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	58f12018-ef71-4a2b-a6f5-6ec3ac19c353	4
308511	bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	58f12018-ef71-4a2b-a6f5-6ec3ac19c353	4
308511	bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic Ointment	SY	58f12018-ef71-4a2b-a6f5-6ec3ac19c353	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
0168-0273-38	00168027338	3.5 g in 1 TUBE	3.5 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINTMENT, USP	E. FOUGERA & CO., A division of Nycomed US Inc. \| Nycomed US Inc.	2009-05-08	HUMAN PRESCRIPTION DRUG LABEL	4