Loteprednol Etabonate

Product NDC: 50383-265
11-digit product format: 503830265
Labeler code: 50383
Product ID: 50383-265_9e3230b5-521e-4426-bdcd-6fb8c38a197f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loteprednol Etabonate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Akorn
Application: ANDA207609
Marketing category: ANDA
Marketing start: 2019-04-18
Marketing end: 0000-00-00
Substance: LOTEPREDNOL ETABONATE
Active strength: 5 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50383-265		I	Inactivated by FDA	2026-08-17
excluded package	package	50383-265	50383-265-05	I	Inactivated by FDA	2026-08-17
excluded package	package	50383-265	50383-265-10	I	Inactivated by FDA	2026-08-17
excluded package	package	50383-265	50383-265-15	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 · 60 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	50383-265-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-265-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-265-10	`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	50383-265-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-265-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-265-10	`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	50383-265-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-265-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-265-10	`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	50383-265-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-265-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-265-10	`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	50383-265-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-265-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-265-10	`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	50383-265-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-265-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-265-10	`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	50383-265-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-265-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-265-10	`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	50383-265-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-265-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-265-10	`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	50383-265-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-265-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-265-10	`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	50383-265-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-265-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-265-10	`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	50383-265-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-265-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-265-10	`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	50383-265-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-265-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-265-10	`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	50383-265-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50383-265-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50383-265-10	`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	50383-265-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50383-265-15	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50383-265-10	`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	50383-265-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50383-265-15	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50383-265-10	`1332a3947898…`	`d4bfe170f9cd…`

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
A207609-001	LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB		2019-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207609-001	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 · 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	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`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	A207609-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207609-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207609-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207609-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207609-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207609-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207609-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207609-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207609-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207609-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207609-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207609-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207609-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207609-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207609-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207609-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207609-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207609-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207609-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207609-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207609-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207609-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207609-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207609-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207609-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207609-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207609-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207609-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207609-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207609-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207609-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207609-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207609-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207609-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207609-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207609-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207609-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207609-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207609-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207609-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4f474382-f6ee-e00d-5df3-bba50cddfd89	Product name	5	20251114
64ba4d79-5363-eefc-3390-ee5d2a50a350	Product name	3	20250304
100e83dc-ec8c-9e2e-76d2-5112415ec972	Product name	3	20241008
4300453c-d545-46d1-b115-18b12b4ccf79	Product name	1	20210525
3f316f1c-2561-47c9-9865-ba2be69e0b3e	Product name	1	20190614
f1ee2aaf-88da-4841-948b-7d3a6af14e35	Product name	1	20181206
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81	Product name	1	20140508
b5c5cd73-a27b-5e41-bd36-3de9471473cd	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-265-05	2024-01-30	C162847	48780-1	1030e365-576b-111a-e063-dadaa90a10e2	Loteprednol Etabonate Ophthalmic Suspension, 0.5%
50383-265-10	2024-01-30	C162847	48780-1	1030e365-576b-111a-e063-dadaa90a10e2	Loteprednol Etabonate Ophthalmic Suspension, 0.5%
50383-265-15	2024-01-30	C162847	48780-1	1030e365-576b-111a-e063-dadaa90a10e2	Loteprednol Etabonate Ophthalmic Suspension, 0.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50383-265-05	Loteprednol Etabonate	1 in 1 CARTON	SUSPENSION/ DROPS	1	8
50383-265-05	Loteprednol Etabonate	5 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	5	8
50383-265-10	Loteprednol Etabonate	10 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	10	8
50383-265-10	Loteprednol Etabonate	1 in 1 CARTON	SUSPENSION/ DROPS	1	8
50383-265-15	Loteprednol Etabonate	15 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	15	8
50383-265-15	Loteprednol Etabonate	1 in 1 CARTON	SUSPENSION/ DROPS	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-265-05	ML - Milliliter	50383-265	eac7d2e4-def7-4b55-b692-ae441d059fff	1	2019-12-10
50383-265-10	ML - Milliliter	50383-265	8c5ab2b2-5d9b-4ec2-b556-23b9a0d88b34	1	2019-06-19
50383-265-15	ML - Milliliter	50383-265	67ded942-92a6-4608-8d16-46c89fcb42fb	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-265	LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [AKORN]	8	Legacy NDC, 6 package rows	20220316_66977c58-1e0c-4add-8ff1-c90050dbcd10.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sentiss Pharmaceuticals LLC	4faa8cbe-2004-e8b5-e063-6394a90a3550	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207609 application number: ANDA207609
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	ARMAS PHARMACEUTICALS INC.	08a091a8-748f-acc4-e063-6394a90af4bc	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207609 application number: ANDA207609

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YEH1EZ96K6	LOTEPREDNOL ETABONATE	82034-46-6	LOTEPREDNOL ETABONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311382	loteprednol etabonate 0.5 % Ophthalmic Suspension	PSN	66977c58-1e0c-4add-8ff1-c90050dbcd10	8
311382	loteprednol etabonate 5 MG/ML Ophthalmic Suspension	SCD	66977c58-1e0c-4add-8ff1-c90050dbcd10	8
311382	loteprednol etabonate 0.5 % Ophthalmic Suspension	SY	66977c58-1e0c-4add-8ff1-c90050dbcd10	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-265-05	50383026505	1 BOTTLE, DROPPER in 1 CARTON (50383-265-05) > 5 mL in 1 BOTTLE, DROPPER	2019-04-18	0000-00-00	No	No	Current
50383-265-10	50383026510	1 BOTTLE, DROPPER in 1 CARTON (50383-265-10) > 10 mL in 1 BOTTLE, DROPPER	2019-04-18	0000-00-00	No	No	Current
50383-265-15	50383026515	1 BOTTLE, DROPPER in 1 CARTON (50383-265-15) > 15 mL in 1 BOTTLE, DROPPER	2019-04-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loteprednol Etabonate Ophthalmic Suspension, 0.5%	Akorn \| Akorn Operating Company LLC	2022-03-15	HUMAN PRESCRIPTION DRUG LABEL	8