BLEPHAMIDE

Product NDC: 0023-0313
11-digit product format: 000230313
Labeler code: 0023
Product ID: 0023-0313_8d42edd1-7710-4781-bb5e-dce8f3424554
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sulfacetamide sodium and prednisolone acetate
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Allergan, Inc.
Application: ANDA087748
Marketing category: ANDA
Marketing start: 1987-01-01
Marketing end: 0000-00-00
Substance: PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
Active strength: 2 mg/g; mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0023-0313		D	Discontinued by firm		2026-08-11
excluded package	package	0023-0313	0023-0313-04	D	Discontinued by firm		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 · 24 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	0023-0313-04	`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	0023-0313-04	`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	0023-0313-04	`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	0023-0313-04	`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	0023-0313-04	`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	0023-0313-04	`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	0023-0313-04	`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	0023-0313-04	`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	0023-0313-04	`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	0023-0313-04	`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	0023-0313-04	`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	0023-0313-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A087748-001	BLEPHAMIDE S.O.P.	PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM	0.2%;10%	OINTMENT / OPHTHALMIC			1986-12-03

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	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC		1986-12-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087748-001	BLEPHAMIDE S.O.P.	0.2%;10%	OINTMENT / OPHTHALMIC	RS	1986-12-03	`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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-0313-04	GM - Gram	0023-0313	d493aab4-0382-476a-ad91-6c957c5c9037	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
prednisolone acetate	ACTIVE INGREDIENT	8B2807733D	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [ALLERGAN, INC. ]	4
sulfacetamide sodium	ACTIVE INGREDIENT	4NRT660KJQ	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [ALLERGAN, INC. ]	4
prednisolone	ACTIVE MOIETY	9PHQ9Y1OLM	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [ALLERGAN, INC. ]	4
sulfacetamide	ACTIVE MOIETY	4965G3J0F5	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [ALLERGAN, INC. ]	4
lanolin alcohols	INACTIVE INGREDIENT	884C3FA9HE	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [ALLERGAN, INC. ]	4
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [ALLERGAN, INC. ]	4
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [ALLERGAN, INC. ]	4
phenylmercuric acetate	INACTIVE INGREDIENT	OSX88361UX	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [ALLERGAN, INC. ]	4
prednisolone acetate	ACTIVE INGREDIENT	8B2807733D	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.]	1
sulfacetamide sodium	ACTIVE INGREDIENT	4NRT660KJQ	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.]	1
prednisolone	ACTIVE MOIETY	9PHQ9Y1OLM	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.]	1
sulfacetamide	ACTIVE MOIETY	4965G3J0F5	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.]	1
lanolin alcohols	INACTIVE INGREDIENT	884C3FA9HE	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.]	1
phenylmercuric acetate	INACTIVE INGREDIENT	OSX88361UX	BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8B2807733D	PREDNISOLONE ACETATE	52-21-1	PREDNISOLONE ACETATE
4NRT660KJQ	SULFACETAMIDE SODIUM	6209-17-2	SULFACETAMIDE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1011987	BLEPHAMIDE 10 % / 0.2 % Ophthalmic Ointment	PSN	24636134-1ca9-4a91-acdf-207b8797570f	1
1011985	sulfacetamide sodium 10 % / prednisoLONE acetate 0.2 % Ophthalmic Ointment	PSN	24636134-1ca9-4a91-acdf-207b8797570f	1
1011987	prednisolone acetate 0.002 MG/MG / sulfacetamide sodium 0.1 MG/MG Ophthalmic Ointment [Blephamide]	SBD	24636134-1ca9-4a91-acdf-207b8797570f	1
1011985	prednisolone acetate 0.002 MG/MG / sulfacetamide sodium 0.1 MG/MG Ophthalmic Ointment	SCD	24636134-1ca9-4a91-acdf-207b8797570f	1
1011987	Blephamide (prednisolone acetate 0.2 % / sulfacetamide sodium 10 % ) Ophthalmic Ointment	SY	24636134-1ca9-4a91-acdf-207b8797570f	1
1011987	Blephamide SOP (prednisolone acetate 0.2 % / sulfacetamide sodium 10 % ) Ophthalmic Ointment	SY	24636134-1ca9-4a91-acdf-207b8797570f	1
1011985	prednisolone acetate 0.2 % / sulfacetamide sodium 10 % Ophthalmic Ointment	SY	24636134-1ca9-4a91-acdf-207b8797570f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-0313-04	00023031304	1 TUBE in 1 CARTON (0023-0313-04) > 3.5 g in 1 TUBE	1 tube	1987-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BLEPHAMIDE ® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile	Allergan, Inc.	2018-06-01	HUMAN PRESCRIPTION DRUG LABEL	7
BLEPHAMIDE ® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10% / 0.2%	Physicians Total Care, Inc.	2012-03-04	HUMAN PRESCRIPTION DRUG LABEL	1