PREDNISOLONE ACETATE

Product NDC: 52959-265
11-digit product format: 529590265
Labeler code: 52959
Product ID: 52959-265_fceefb90-8d05-40f0-b612-107685339aff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prednisolone acetate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: H.J. Harkins Company, Inc.
Application: NDA017011
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1997-08-19
Marketing end: 0000-00-00
Substance: PREDNISOLONE ACETATE
Active strength: 10 mg/mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-265		I	Inactivated by FDA	2026-08-11
excluded package	package	52959-265	52959-265-05	I	Inactivated by FDA	2026-08-11
excluded package	package	52959-265	52959-265-10	I	Inactivated by FDA	2026-08-11
excluded package	package	52959-265	52959-265-15	I	Inactivated by FDA	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 2 · 88 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	52959-265-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-265-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-265-10	`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	52959-265-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-265-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-265-10	`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	52959-265-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-265-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-265-10	`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	52959-265-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-265-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-265-10	`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	52959-265-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-265-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-265-10	`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	52959-265-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-265-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-265-10	`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	52959-265-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-265-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-265-10	`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	52959-265-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-265-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-265-10	`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	52959-265-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-265-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-265-10	`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	52959-265-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-265-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-265-10	`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	52959-265-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-265-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-265-10	`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	52959-265-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-265-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-265-10	`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	52959-265-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-265-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-265-10	`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	52959-265-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-265-15	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-265-10	`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	52959-265-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-265-15	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-265-10	`1332a3947898…`	`d4bfe170f9cd…`

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
N017011-001	PRED FORTE	PREDNISOLONE ACETATE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017011-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`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	N017011-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017011-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017011-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017011-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017011-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017011-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017011-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017011-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017011-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017011-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017011-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017011-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017011-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017011-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017011-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017011-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017011-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017011-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017011-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017011-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017011-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017011-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017011-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017011-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017011-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017011-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017011-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017011-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017011-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017011-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017011-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017011-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017011-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017011-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017011-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017011-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017011-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017011-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017011-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017011-001	AB	1	`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
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
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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-265-05	2019-11-13	C162847	48780-1	97449f38-ca2e-f6ea-e053-dbdaa90aa703	PREDNISOLONE ACETATE ophthalmic suspension, USP 1.0%
52959-265-10	2019-11-13	C162847	48780-1	97449f38-ca2e-f6ea-e053-dbdaa90aa703	PREDNISOLONE ACETATE ophthalmic suspension, USP 1.0%
52959-265-15	2019-11-13	C162847	48780-1	97449f38-ca2e-f6ea-e053-dbdaa90aa703	PREDNISOLONE ACETATE ophthalmic suspension, USP 1.0%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-265-05	PREDNISOLONE ACETATE	5 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	5	3
52959-265-10	PREDNISOLONE ACETATE	10 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	10	3
52959-265-15	PREDNISOLONE ACETATE	15 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	15	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-265-05	ML - Milliliter	52959-265	e67eb6c9-eb3a-4616-a278-48825563f1f5	1	2012-07-24
52959-265-10	ML - Milliliter	52959-265	13242593-79b2-4fbd-b4af-580cb3fe5344	1	2012-07-24
52959-265-15	ML - Milliliter	52959-265	74fca8f0-74e1-4f73-8dbe-5b4d984d7a95	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
prednisolone acetate	ACTIVE INGREDIENT	8B2807733D	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
prednisolone	ACTIVE MOIETY	9PHQ9Y1OLM	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
sodium bisulfite	INACTIVE INGREDIENT	TZX5469Z6I	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-265	PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.]	3	Legacy NDC, 3 package rows	20111118_c77597c4-8add-4d2a-b8c1-e526cbe22dcb.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	dd32d625-fb2f-4c51-89fe-cdccdf0201b9	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Sportpharm LLC	02fc6f0b-d053-49e1-82de-f272dd05d529	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	388abc87-cd5a-4e88-8675-7bf0c5ce7af5	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	NuCare Pharmaceuticals,Inc.	ab72cf3d-7660-41b1-e053-2995a90a7f44	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Pacific Pharma, Inc.	1474d1df-70b6-4b1e-86d1-3349aa6d42fb	2024-03-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PRED FORTE	PREDNISOLONE ACETATE	Allergan, Inc.	00a5aa88-e361-4ea7-8922-530c738b726e	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Asclemed USA, Inc.	232e40a5-17c5-4cf3-9e3b-110a194ad4be	2021-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8B2807733D	PREDNISOLONE ACETATE	52-21-1	PREDNISOLONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	c77597c4-8add-4d2a-b8c1-e526cbe22dcb	3
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	c77597c4-8add-4d2a-b8c1-e526cbe22dcb	3
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	c77597c4-8add-4d2a-b8c1-e526cbe22dcb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52959-265-05	52959026505	5 mL in 1 BOTTLE, DROPPER	5 ml	Historical
52959-265-10	52959026510	10 mL in 1 BOTTLE, DROPPER	10 ml	Historical
52959-265-15	52959026515	15 mL in 1 BOTTLE, DROPPER	15 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREDNISOLONE ACETATE ophthalmic suspension, USP 1.0%	H.J. Harkins Company, Inc. \| Pacific Pharma, Inc.	2011-11-17	HUMAN PRESCRIPTION DRUG LABEL	3