NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

Product NDC: 72189-038
11-digit product format: 721890038
Labeler code: 72189
Product ID: 72189-038_947bcaeb-59db-332e-e053-2995a90aab81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Direct_Rx
Application: NDA050065
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-10-09
Marketing end: 0000-00-00
Substance: DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 1 mg/g; mg/g; [iU]/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	72189-038		I	Inactivated by FDA		2026-08-03
excluded package	package	72189-038	72189-038-35	I	Inactivated by FDA		2026-08-03

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 · 30 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	72189-038-35	`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	72189-038-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72189-038-35	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72189-038-35	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72189-038-35	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72189-038-35	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72189-038-35	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-038-35	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-038-35	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72189-038-35	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72189-038-35	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72189-038-35	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	72189-038-35	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	72189-038-35	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	72189-038-35	`1332a3947898…`	`d4bfe170f9cd…`

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
N050065-002	MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050065-002	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`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	N050065-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050065-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050065-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050065-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050065-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050065-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050065-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050065-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050065-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050065-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050065-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050065-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050065-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050065-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050065-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050065-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050065-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050065-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050065-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050065-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050065-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050065-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050065-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050065-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050065-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050065-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050065-002	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050065-002	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050065-002	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050065-002	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050065-002	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050065-002	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050065-002	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050065-002	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050065-002	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050065-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050065-002	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050065-002	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050065-002	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050065-002	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72189-038-35	2023-01-30	C162847	48780-1	f386c64a-1106-0266-e053-dadaa90a7c1a	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-038-35	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	3.5 g in 1 TUBE	OINTMENT	3.5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-038-35	GM - Gram	72189-038	03bd954f-f778-418d-a65a-5e96b8cd8ea5	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-038	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [DIRECT_RX]	1	Legacy NDC, 1 package rows	20191210_947bcaeb-59da-332e-e053-2995a90aab81.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	a7e55c43-4345-4710-e053-2995a90aeee7	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Sandoz Inc	7f2e3c46-9f39-45e7-99a9-64cc4f6f649d	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	A-S Medication Solutions	6791e6c3-514d-4b98-8887-ca2b894576b5	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065
MAXITROL	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Sandoz Inc	5776c435-ac60-49b6-8db1-23a3012b9155	2023-12-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065
MAXITROL	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Novartis Pharmaceuticals Corporation	22c6d2db-85af-4a3b-a014-80d901a86717	2023-06-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Proficient Rx LP	aa7b8a3f-06dd-4190-96a5-f86195bd2197	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
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
309679	dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	947bcaeb-59da-332e-e053-2995a90aab81	1
309679	dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	947bcaeb-59da-332e-e053-2995a90aab81	1
309679	dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic Ointment	SY	947bcaeb-59da-332e-e053-2995a90aab81	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-038-35	72189003835	3.5 g in 1 TUBE (72189-038-35)	3.5 g	2019-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Direct_Rx	2019-10-09	HUMAN PRESCRIPTION DRUG LABEL	1