Sulfacetamide Sodium

Product NDC: 71205-689
11-digit product format: 712050689
Labeler code: 71205
Product ID: 71205-689_2b4f125c-338e-479f-8feb-b82324230c65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sulfacetamide sodium
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Proficient Rx LP
Application: ANDA040066
Marketing category: ANDA
Marketing start: 1994-12-28
Substance: SULFACETAMIDE SODIUM
Active strength: 100 mg/mL
Pharmacologic classes: 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
A040066-001	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040066-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`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	A040066-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040066-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040066-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040066-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040066-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040066-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040066-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040066-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040066-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040066-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040066-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040066-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040066-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040066-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040066-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040066-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040066-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040066-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040066-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040066-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040066-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040066-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040066-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040066-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040066-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040066-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040066-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040066-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040066-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040066-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040066-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040066-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040066-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040066-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040066-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040066-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040066-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040066-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040066-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040066-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULFACETAMIDE SODIUM	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1006120	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
2b4f125c-338e-479f-8feb-b82324230c65	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4073022c-5d5d-48f5-82ed-091ad146a4b2	Product name	1	20171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5	Product name	1	20150828
0304b7d2-7a07-d53b-750f-36012ae6612e	Product name	1	20140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71205-689-15	Sulfacetamide Sodium	1 in 1 CARTON	SOLUTION/ DROPS	1		1
71205-689-15	Sulfacetamide Sodium	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-689	SULFACETAMIDE SODIUM SOLUTION/ DROPS [PROFICIENT RX LP]	1	Current NDC, Legacy NDC, 2 package rows	20220904_2b4f125c-338e-479f-8feb-b82324230c65.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
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	A-S Medication Solutions	f212af23-be3d-4e82-9f6f-5ddce12a89da	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Preferred Pharmaceuticals, Inc	cf0cc763-49b5-435d-852b-e7617c8d3286	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	NuCare Pharmaceuticals,Inc.	9910ec80-e37c-6a83-e053-2995a90a8237	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Bausch & Lomb Incorporated	6c1b2658-e756-4f31-9bc8-f99a0baa4637	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Proficient Rx LP	2b4f125c-338e-479f-8feb-b82324230c65	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066 ndc (product): 71205-689
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Asclemed USA, Inc.	129d5dd9-32a4-4398-862d-820cd4468448	2020-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4NRT660KJQ	SULFACETAMIDE SODIUM	6209-17-2	SULFACETAMIDE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1006120	sulfacetamide sodium 10 % Ophthalmic Solution	PSN	2b4f125c-338e-479f-8feb-b82324230c65	1
1006120	sulfacetamide sodium 100 MG/ML Ophthalmic Solution	SCD	2b4f125c-338e-479f-8feb-b82324230c65	1
1006120	sulfacetamide sodium 10 % Eye Drops	SY	2b4f125c-338e-479f-8feb-b82324230c65	1
1006120	sulfacetamide sodium 10 % Ophthalmic Solution	SY	2b4f125c-338e-479f-8feb-b82324230c65	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-689-15	71205068915	1 BOTTLE, DROPPER in 1 CARTON (71205-689-15) / 15 mL in 1 BOTTLE, DROPPER	2022-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfacetamide Sodium Ophthalmic Solution, USP 10% (Sterile)	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	1