Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC: 13985-744
11-digit product format: 139850744
Labeler code: 13985
Product ID: 13985-744_d178cf8f-5bce-43f8-b436-cd963b428bee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: MWI
Application: ANDA064063
Marketing category: ANDA
Marketing start: 1994-07-25
Marketing end: 0000-00-00
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength: 4 mg/g; [USP'U]/g; mg/g
Pharmacologic classes: Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [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	13985-744		D	Discontinued by firm		2026-08-11
excluded package	package	13985-744	13985-744-35	D	Discontinued by firm		2026-08-11

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 · 36 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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`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	13985-744-35	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	13985-744-35	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	13985-744-35	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	13985-744-35	`bd6a592717d7…`	`303034d00443…`

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
A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT		1994-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064063-001	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 · 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	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064063-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1994-07-25	`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	A064063-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064063-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064063-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064063-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064063-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064063-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064063-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064063-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064063-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064063-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064063-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064063-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064063-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064063-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064063-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064063-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064063-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064063-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064063-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064063-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064063-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064063-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064063-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064063-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064063-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064063-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064063-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064063-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064063-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064063-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064063-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064063-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064063-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064063-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064063-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064063-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064063-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064063-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064063-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064063-001	AT	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13985-744-35	2025-12-29	C162847	48780-1	d6a99b39-4e3c-a426-e053-dadaa90af4c2	Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, USP
13985-744-35	2022-01-28	C162847	48780-1	d6a99b39-4e3c-a426-e053-dadaa90af4c2	Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13985-744	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [MWI]	2	Legacy NDC	20170327_3cd3c3bd-9214-4ded-838d-1bc0ff9adc61.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 · 7 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 SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	c3b6004a-8cfc-d5f8-e053-2a95a90a3efb	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064063 application number: ANDA064063
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	Preferred Pharmaceuticals Inc.	e42d4837-77c2-40c3-8705-20966a51a822	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064063 application number: ANDA064063
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	f1a05d5f-74f2-17a1-e053-2995a90ab0e7	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064063 application number: ANDA064063
Neo/Poly-B/Dex Ophth Oint	NEO/POLY-B/DEX OPHTH OINT	Direct_Rx	0ec1dfdf-b63f-fb0c-e063-6294a90a843d	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064063 application number: ANDA064063
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	A-S Medication Solutions	0d273133-0ce9-4fe6-b873-7f85aac25486	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064063 application number: ANDA064063
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	Bausch & Lomb Incorporated	4456d10b-9995-4430-b692-a8859ea36deb	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064063 application number: ANDA064063
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE	Proficient Rx LP	21c9b34c-af88-4c9e-9b6c-32d78d34ba7e	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064063 application number: ANDA064063

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13985-744-35	13985074435	1 TUBE in 1 CARTON (13985-744-35) > 3.5 g in 1 TUBE	1 tube	1994-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, USP	MWI \| Bausch & Lomb Incorporated	2016-10-26	HUMAN PRESCRIPTION DRUG LABEL	2