Neomycin Polymyxin B Sulfates and Dexamethasone

Product NDC: 53002-9510
11-digit product format: 530029510
Labeler code: 53002
Product ID: 53002-9510_a1cf530d-7946-4712-b4f0-d8e5631a11a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA064135
Marketing category: ANDA
Marketing start: 1995-09-13
Marketing end: 0000-00-00
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength: 4 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	53002-9510		I	Inactivated by FDA		2026-08-11
excluded package	package	53002-9510	53002-9510-1	I	Inactivated by FDA		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 · 22 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	53002-9510-1	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	53002-9510-1	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	53002-9510-1	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	53002-9510-1	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	53002-9510-1	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	53002-9510-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-9510-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-9510-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-9510-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
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	53002-9510-1	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	53002-9510-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A064135-001	DEXASPORIN	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT		1995-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064135-001	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	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064135-001	DEXASPORIN	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1995-09-13	`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	A064135-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064135-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064135-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064135-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064135-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064135-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064135-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064135-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064135-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064135-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064135-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064135-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064135-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064135-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064135-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064135-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064135-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064135-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064135-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064135-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064135-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064135-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064135-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064135-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064135-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064135-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064135-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064135-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064135-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064135-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064135-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064135-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064135-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064135-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064135-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064135-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064135-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064135-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064135-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064135-001	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
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
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile) Rx only
2023-06-07	Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile) Rx only
2023-01-30	Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile) Rx only
2020-12-17	Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile) Rx only
2020-01-31	Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-9510-1	Neomycin Polymyxin B Sulfates and Dexamethasone	5 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	5		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-9510	NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 1 package rows	20230609_1a5eb12f-7a07-405b-aa0f-7a2e1a197c4d.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 Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	A-S Medication Solutions	adcc540e-9275-4a7c-918a-36fa2314acd2	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064135 application number: ANDA064135
Neomycin Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Preferred Pharmaceuticals, Inc.	449a6fd8-c2ac-40d0-b74a-e5c7fc6670f3	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064135 application number: ANDA064135
NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION/ DROPS	DirectRx	d5e00bad-abb4-63ad-e053-2a95a90a5abb	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064135 application number: ANDA064135
Neomycin Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Bausch & Lomb Incorporated	d6d78668-a978-4cd3-bbcd-1293b5044ec9	2024-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064135 application number: ANDA064135
Neomycin Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	691bc5ca-5d61-60c2-e053-2991aa0abb93	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064135 application number: ANDA064135
Neomycin Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Proficient Rx LP	548089f3-29d8-4ba8-af21-9e04356ac29c	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064135 application number: ANDA064135

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309680	neomycin sulfate 3.5 MG/ML / polymyxin B sulfate 10,000 UNT/mL / dexAMETHasone 0.1 % Ophthalmic Suspension	PSN	1a5eb12f-7a07-405b-aa0f-7a2e1a197c4d	5
309680	dexamethasone 1 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Suspension	SCD	1a5eb12f-7a07-405b-aa0f-7a2e1a197c4d	5
309680	dexamethasone 0.1 % / neomycin 0.35 % / polymyxin B 10,000 UNT per ML Ophthalmic Suspension	SY	1a5eb12f-7a07-405b-aa0f-7a2e1a197c4d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-9510-1	53002951001	5 mL in 1 BOTTLE, DROPPER (53002-9510-1)	5 ml	2018-10-01	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 Suspension, USP (Sterile) Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5