SULFACETAMIDE SODIUM

Product NDC: 68387-491
11-digit product format: 683870491
Labeler code: 68387
Product ID: 68387-491_b3fe37b1-8adc-4728-a7c7-9fec050b21ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SULFACETAMIDE SODIUM
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Keltman Pharmaceuticals Inc.
Application: ANDA089560
Marketing category: ANDA
Marketing start: 2010-01-10
Marketing end: 0000-00-00
Substance: SULFACETAMIDE SODIUM
Active strength: 100 mg/mL
Pharmacologic classes: Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
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	68387-491		I	Inactivated by FDA		2026-08-17
excluded package	package	68387-491	68387-491-01	I	Inactivated by FDA		2026-08-17

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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`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	68387-491-01	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A089560-001	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1988-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089560-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A089560-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089560-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089560-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089560-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089560-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089560-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089560-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089560-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089560-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089560-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089560-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089560-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089560-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089560-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089560-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089560-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089560-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089560-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089560-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089560-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089560-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089560-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089560-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089560-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089560-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089560-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089560-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089560-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089560-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089560-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089560-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089560-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089560-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089560-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089560-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089560-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089560-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089560-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089560-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089560-001	AT	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68387-491-01	2019-10-29	C162847	48780-1	960f7f55-cfa4-8e05-e053-dbdaa90a074a	SULFACETAMIDE SODIUM - sulfacetamide sodium solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68387-491-01	SULFACETAMIDE SODIUM	15 mL in 1 BOTTLE	SOLUTION	15		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68387-491-01	ML - Milliliter	68387-491	f09b07e6-f977-4315-84b2-85278c800b39	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFACETAMIDE SODIUM	ACTIVE INGREDIENT	4NRT660KJQ	SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]	4
SULFACETAMIDE	ACTIVE MOIETY	4965G3J0F5	SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]	4
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]	4
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]	4
SODIUM THIOSULFATE	INACTIVE INGREDIENT	HX1032V43M	SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68387-491	SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]	4	Legacy NDC, 1 package rows	20101005_1c490337-c060-4f85-9998-f292edea92eb.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	Asclemed USA, Inc.	c4c29e13-8303-4a9a-bb47-d7413eaf2f26	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089560 application number: ANDA089560

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	1c490337-c060-4f85-9998-f292edea92eb	4
1006120	sulfacetamide sodium 100 MG/ML Ophthalmic Solution	SCD	1c490337-c060-4f85-9998-f292edea92eb	4
1006120	sulfacetamide sodium 10 % Eye Drops	SY	1c490337-c060-4f85-9998-f292edea92eb	4
1006120	sulfacetamide sodium 10 % Ophthalmic Solution	SY	1c490337-c060-4f85-9998-f292edea92eb	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68387-491-01	68387049101	15 mL in 1 BOTTLE	15 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SULFACETAMIDE SODIUM - sulfacetamide sodium solution	Keltman Pharmaceuticals Inc. \| Sandhills Packaging	2010-07-12	HUMAN PRESCRIPTION DRUG LABEL	4