PRED FORTE

Product NDC: 11980-180
11-digit product format: 119800180
Labeler code: 11980
Product ID: 11980-180_bff1726c-7781-49de-8a61-bc37a755c92b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prednisolone acetate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Allergan, Inc.
Application: NDA017011
Marketing category: NDA
Marketing start: 1973-06-01
Marketing end: 2027-05-31
Substance: PREDNISOLONE ACETATE
Active strength: 10 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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 package	package	11980-180	11980-180-01	D	Discontinued by firm	2026-08-10
excluded package	package	11980-180	11980-180-06	D	Discontinued by firm	2026-08-10
excluded package	package	11980-180	11980-180-11	D	Discontinued by firm	2026-08-10
excluded package	package	11980-180	11980-180-15	D	Discontinued by firm	2026-08-10

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 · 33 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	11980-180-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	11980-180-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	11980-180-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	11980-180-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	11980-180-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	11980-180-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	11980-180-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	11980-180-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	11980-180-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	11980-180-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	11980-180-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	11980-180-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	11980-180-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	11980-180-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	11980-180-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	11980-180-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	11980-180-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	11980-180-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	11980-180-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	11980-180-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	11980-180-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	11980-180-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	11980-180-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	11980-180-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	11980-180-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	11980-180-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	11980-180-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	11980-180-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	11980-180-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	11980-180-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	11980-180-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	11980-180-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	11980-180-06	`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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: PRED FORTE

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISOLONE ACETATE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8B2807733D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1376336	Internal RxNorm lookup
1548724	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
00a5aa88-e361-4ea7-8922-530c738b726e	Available on FDA.report

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
9f10552a-9a7b-8e6c-3223-dc44310af6cf	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11980-180-01	PRED FORTE	1 in 1 CARTON	SUSPENSION/ DROPS	1	16
11980-180-01	PRED FORTE	1 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	1	16
11980-180-05	PRED FORTE	5 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	5	16
11980-180-05	PRED FORTE	1 in 1 CARTON	SUSPENSION/ DROPS	1	16
11980-180-06	PRED FORTE	5 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	5	16
11980-180-06	PRED FORTE	1 in 1 CARTON	SUSPENSION/ DROPS	1	16
11980-180-10	PRED FORTE	1 in 1 CARTON	SUSPENSION/ DROPS	1	16
11980-180-10	PRED FORTE	10 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	10	16
11980-180-11	PRED FORTE	1 in 1 CARTON	SUSPENSION/ DROPS	1	16
11980-180-11	PRED FORTE	10 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	10	16
11980-180-15	PRED FORTE	15 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	15	16
11980-180-15	PRED FORTE	1 in 1 CARTON	SUSPENSION/ DROPS	1	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11980-180-01	ML - Milliliter	11980-180	0bdb4a34-c31a-4af7-b878-34bf866f8324	1	2012-07-24
11980-180-05	ML - Milliliter	11980-180	64bf6d20-fdfd-4a22-b698-17502cae0856	1	2012-07-24
11980-180-10	ML - Milliliter	11980-180	efd9395f-4637-4d5d-ad51-326f23b157e7	1	2012-07-24
11980-180-15	ML - Milliliter	11980-180	53312c2d-bd89-4f83-9470-8bceb6be7b2f	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11980-180	PRED FORTE (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	15	Current NDC, Legacy NDC, 12 package rows	20241207_00a5aa88-e361-4ea7-8922-530c738b726e.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 ndc (product): 11980-180
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
1548724	Pred Forte 1 % Ophthalmic Suspension	PSN	00a5aa88-e361-4ea7-8922-530c738b726e	16
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	00a5aa88-e361-4ea7-8922-530c738b726e	16
1548724	prednisolone acetate 10 MG/ML Ophthalmic Suspension [Pred Forte]	SBD	00a5aa88-e361-4ea7-8922-530c738b726e	16
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	00a5aa88-e361-4ea7-8922-530c738b726e	16
1548724	Pred Forte 1 % Ophthalmic Suspension	SY	00a5aa88-e361-4ea7-8922-530c738b726e	16
1548724	Pred Forte 10 MG/ML Ophthalmic Suspension	SY	00a5aa88-e361-4ea7-8922-530c738b726e	16
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	00a5aa88-e361-4ea7-8922-530c738b726e	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
11980-180-01	11980018001	1 BOTTLE, DROPPER in 1 CARTON (11980-180-01) > 1 mL in 1 BOTTLE, DROPPER	1973-06-01	0000-00-00	No	No	Current
11980-180-05	11980018005	1 BOTTLE, DROPPER in 1 CARTON (11980-180-05) / 5 mL in 1 BOTTLE, DROPPER	1973-06-01	2027-05-31	No	No	Current
11980-180-06	11980018006	1 BOTTLE, DROPPER in 1 CARTON (11980-180-06) > 5 mL in 1 BOTTLE, DROPPER	1973-06-01	0000-00-00	No	No	Current
11980-180-10	11980018010	1 BOTTLE, DROPPER in 1 CARTON (11980-180-10) / 10 mL in 1 BOTTLE, DROPPER	1973-06-01	2026-08-31	No	No	Current
11980-180-11	11980018011	1 BOTTLE, DROPPER in 1 CARTON (11980-180-11) > 10 mL in 1 BOTTLE, DROPPER	1973-06-01	0000-00-00	No	No	Current
11980-180-15	11980018015	1 BOTTLE, DROPPER in 1 CARTON (11980-180-15) > 15 mL in 1 BOTTLE, DROPPER	1973-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRED FORTE ® (prednisolone acetate ophthalmic suspension, USP) 1% sterile	Allergan, Inc.	2024-02-02	HUMAN PRESCRIPTION DRUG LABEL	16