Sulfacetamide Sodium

Product NDC: 45802-896
Requested package NDC: 45802-896-26
11-digit product format: 458020896
Labeler code: 45802
Product ID: 45802-896_03f16a28-7c10-4fa0-a4c8-ac29335c6be7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfacetamide Sodium
Dosage form: LOTION
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA078649
Marketing category: ANDA
Marketing start: 2012-10-17
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
A078649-001	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB		2009-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078649-001	AB

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	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`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	A078649-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078649-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078649-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078649-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078649-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078649-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078649-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078649-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078649-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078649-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078649-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078649-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078649-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078649-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078649-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078649-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078649-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078649-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078649-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078649-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078649-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078649-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078649-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078649-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078649-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078649-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078649-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078649-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078649-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078649-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078649-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078649-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078649-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078649-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078649-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078649-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078649-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078649-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078649-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078649-001	AB	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
1006688	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
4fb4d39a-330e-4c84-abbc-3b33b36b206f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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
45802-896-26	Sulfacetamide Sodium	118 mL in 1 BOTTLE, PLASTIC	LOTION	118		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-896-26	ML - Milliliter	45802-896	d8ea719a-62c7-4f74-bcf6-5584e4a8260d	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFACETAMIDE SODIUM	ACTIVE INGREDIENT	4NRT660KJQ	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
SULFACETAMIDE	ACTIVE MOIETY	4965G3J0F5	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
DIETHANOLAMINE	INACTIVE INGREDIENT	AZE05TDV2V	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
LAURIC DIETHANOLAMIDE	INACTIVE INGREDIENT	I29I2VHG38	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SULFACETAMIDE SODIUM LOTION [PERRIGO NEW YORK INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-896	SULFACETAMIDE SODIUM LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]	11	Current NDC, Legacy NDC, 1 package rows	20240329_4fb4d39a-330e-4c84-abbc-3b33b36b206f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Padagis Israel Pharmaceuticals Ltd	4fb4d39a-330e-4c84-abbc-3b33b36b206f	2023-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078649 application number: ANDA078649 ndc (package): 45802-896-26 ndc (product): 45802-896 ndc11 (package): 45802089626

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
1006688	sulfacetamide sodium 10 % Topical Lotion	PSN	4fb4d39a-330e-4c84-abbc-3b33b36b206f	12
1006688	sulfacetamide sodium 100 MG/ML Topical Lotion	SCD	4fb4d39a-330e-4c84-abbc-3b33b36b206f	12
1006688	sulfacetamide sodium 10 % Topical Lotion	SY	4fb4d39a-330e-4c84-abbc-3b33b36b206f	12
1006688	sulfacetamide sodium 10 % Topical Suspension	SY	4fb4d39a-330e-4c84-abbc-3b33b36b206f	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-896-26	45802089626	118 mL in 1 BOTTLE, PLASTIC (45802-896-26)	118 ml	2012-10-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)	Padagis Israel Pharmaceuticals Ltd	2023-04-01	HUMAN PRESCRIPTION DRUG LABEL	12