Bacitracin Zinc and Polymyxin B Sulfate

Product NDC: 68788-7599
11-digit product format: 687887599
Labeler code: 68788
Product ID: 68788-7599_fbc413a0-6310-42e2-8860-13615240c362
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bacitracin Zinc and Polymyxin B Sulfate
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA064046
Marketing category: ANDA
Marketing start: 2020-03-27
Marketing end: 0000-00-00
Substance: BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength: 500 [USP'U]/g; [USP'U]/g
Pharmacologic classes: Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [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	68788-7599		D	Discontinued by firm		2026-08-17
excluded package	package	68788-7599	68788-7599-3	D	Discontinued by firm		2026-08-17

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7599-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7599-3	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	BACITRACIN ZINC; POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-01-26

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	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		RS	1995-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-01-26	`e64feba35796…`

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	A064046-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064046-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064046-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064046-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064046-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064046-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064046-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064046-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064046-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064046-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064046-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064046-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064046-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064046-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064046-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064046-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064046-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064046-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064046-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064046-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064046-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064046-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064046-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064046-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064046-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064046-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064046-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064046-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064046-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064046-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064046-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064046-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064046-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064046-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064046-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064046-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064046-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064046-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064046-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064046-001	AT	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7599-3	GM - Gram	68788-7599	177dcb01-b243-41eb-89de-695e982c0f0d	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7599	BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [PREFERRED PHARMACEUTICALS INC.]	6	Legacy NDC	20250207_e6447ebb-9224-4a3e-ad74-0c923414aa07.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bacitracin Zinc and Polymyxin B Sulfate	BACITRACIN ZINC AND POLYMYXIN B SULFATE	A-S Medication Solutions	51f6eac3-205e-4beb-8522-6ba2c593f350	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064046 application number: ANDA064046
Bacitracin Zinc and Polymyxin B Sulfate	BACITRACIN ZINC AND POLYMYXIN B SULFATE	A-S Medication Solutions	19b4cfab-5927-47c5-a032-58ab2998d9c7	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064046 application number: ANDA064046
Bacitracin Zinc and Polymyxin B Sulfate	BACITRACIN ZINC AND POLYMYXIN B SULFATE	NuCare Pharmaceuticals,Inc.	a73654f4-949d-3da4-e053-2995a90a1fc3	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064046 application number: ANDA064046
Bacitracin Zinc and Polymyxin B Sulfate	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Bausch & Lomb Incorporated	1b317249-30eb-4415-8a1c-cfedb4ba3549	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064046 application number: ANDA064046

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7599-3	68788759903	1 TUBE in 1 CARTON (68788-7599-3) > 3.5 g in 1 TUBE	1 tube	2020-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP (Sterile) Rx only	Preferred Pharmaceuticals Inc.	2025-01-06	HUMAN PRESCRIPTION DRUG LABEL	6