Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Product NDC: 68071-1650
11-digit product format: 680711650
Labeler code: 68071
Product ID: 68071-1650_1d4de4f7-e86f-d269-e063-6294a90ab688
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA074449
Marketing category: ANDA
Marketing start: 1995-12-29
Substance: PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
Active strength: 2.3; 100 mg/mL; mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULFACETAMIDE SODIUM	2.3 mg/mL
PREDNISOLONE SODIUM PHOSPHATE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4NRT660KJQ	Internal UNII lookup
IV021NXA9J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1012021	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
835def0b-ed5a-61a0-e053-2a91aa0ae7ae	Available on FDA.report

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#

Effective, Related label table
Effective	Related label
2023-04-06	Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/0.23% (prednisolone phosphate) (Sterile)
2023-01-30	Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/0.23% (prednisolone phosphate) (Sterile)
2021-02-11	Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/0.23% (prednisolone phosphate) (Sterile)
2021-01-29	Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/0.23% (prednisolone phosphate) (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-1650-5	Sulfacetamide Sodium and Prednisolone Sodium Phosphate	5 mL in 1 BOX	SOLUTION/ DROPS	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1650	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240716_835def0b-ed5a-61a0-e053-2a91aa0ae7ae.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 ndc (product): 68071-1650
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
IV021NXA9J	PREDNISOLONE SODIUM PHOSPHATE	125-02-0	PREDNISOLONE SODIUM PHOSPHATE
4NRT660KJQ	SULFACETAMIDE SODIUM	6209-17-2	SULFACETAMIDE SODIUM

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	835def0b-ed5a-61a0-e053-2a91aa0ae7ae	4
1012021	prednisolone sodium phosphate 2.5 MG/ML / sulfacetamide sodium 100 MG/ML Ophthalmic Solution	SCD	835def0b-ed5a-61a0-e053-2a91aa0ae7ae	4
1012021	prednisolone sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic Solution	SY	835def0b-ed5a-61a0-e053-2a91aa0ae7ae	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1650-5	68071165005	5 mL in 1 BOX (68071-1650-5)	5 ml	2019-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/0.23% (prednisolone phosphate) (Sterile)	NuCare Pharmaceuticals,Inc.	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	4