Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Product NDC: 21695-186
11-digit product format: 216950186
Labeler code: 21695
Product ID: 21695-186_e5a2f3a5-2b9d-4d02-ad5c-e6a890569363
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sulfacetamide sodium and prednisolone sodium phosphate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Rebel Distributors Corp
Application: ANDA074449
Marketing category: ANDA
Marketing start: 1995-12-29
Marketing end: 0000-00-00
Substance: SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE
Active strength: 100 mg/mL; mg/mL
Pharmacologic classes: Sulfonamide Antibacterial [EPC],Sulfonamides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	21695-186		I	Inactivated by FDA		2026-08-11
excluded package	package	21695-186	21695-186-05	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 · 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	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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`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	21695-186-05	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-186-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-186-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-186-05	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-186-05	`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
A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-12-29

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074449-001	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS / OPHTHALMIC	RS	1995-12-29	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3fecff3-fb51-4f66-b443-a130905bb500	Product name	1	20250804
3a7a0034-a88d-88c3-f43e-ea34c6a216de	Product name	2	20250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659	Product name	2	20250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
0304b7d2-7a07-d53b-750f-36012ae6612e	Product name	1	20140508
18d57d04-4a34-a130-5dd5-b7fc47f3b567	Product name	1	20140508
379bc253-901a-e6e1-92b7-0fc574249e07	Product name	1	20140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6	Product name	1	20140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
9f10552a-9a7b-8e6c-3223-dc44310af6cf	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-186-05	2019-09-24	C162847	48780-1	934fe258-4737-48b1-e053-8cdaa90a720a	Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-186-05	Sulfacetamide Sodium and Prednisolone Sodium Phosphate	5 mL in 1 BOTTLE	SOLUTION	5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-186-05	ML - Milliliter	21695-186	897f448e-94e9-4d03-b4be-02c8e5c8262b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
prednisolone sodium phosphate	ACTIVE INGREDIENT	IV021NXA9J	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
sulfacetamide sodium	ACTIVE INGREDIENT	4NRT660KJQ	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
prednisolone	ACTIVE MOIETY	9PHQ9Y1OLM	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
sulfacetamide	ACTIVE MOIETY	4965G3J0F5	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
thimerosal	INACTIVE INGREDIENT	2225PI3MOV	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-186	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110201_e5a2f3a5-2b9d-4d02-ad5c-e6a890569363.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfacetamide Sodium and Prednisolone Sodium Phosphate	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	NuCare Pharmaceuticals,Inc.	835def0b-ed5a-61a0-e053-2a91aa0ae7ae	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074449 application number: ANDA074449
Sulfacetamide Sodium and Prednisolone Sodium Phosphate	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	Bausch & Lomb Incoporated	9ec403eb-b5df-4e41-9e17-9d9d8ecac3f3	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074449 application number: ANDA074449

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4NRT660KJQ	SULFACETAMIDE SODIUM	6209-17-2	SULFACETAMIDE SODIUM
IV021NXA9J	PREDNISOLONE SODIUM PHOSPHATE	125-02-0	PREDNISOLONE SODIUM PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1012021	prednisoLONE sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic Solution	PSN	e5a2f3a5-2b9d-4d02-ad5c-e6a890569363	1
1012021	prednisolone sodium phosphate 2.5 MG/ML / sulfacetamide sodium 100 MG/ML Ophthalmic Solution	SCD	e5a2f3a5-2b9d-4d02-ad5c-e6a890569363	1
1012021	prednisolone sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic Solution	SY	e5a2f3a5-2b9d-4d02-ad5c-e6a890569363	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-186-05	21695018605	5 mL in 1 BOTTLE	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution	Rebel Distributors Corp	2011-01-26	HUMAN PRESCRIPTION DRUG LABEL	1