Flurbiprofen Sodium

Product NDC: 21695-615
11-digit product format: 216950615
Labeler code: 21695
Product ID: 21695-615_725fb4ac-3bd2-4c0f-829f-a3a40863ebce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flurbiprofen Sodium
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Rebel Distributors Corp
Application: ANDA074447
Marketing category: ANDA
Marketing start: 1995-01-04
Marketing end: 0000-00-00
Substance: FLURBIPROFEN SODIUM
Active strength: 0 mg/mL
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
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	21695-615		I	Inactivated by FDA		2026-08-11
excluded package	package	21695-615	21695-615-25	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 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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`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	21695-615-25	`110d247fa046…`	`a55b01930146…`

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
A074447-001	FLURBIPROFEN SODIUM	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074447-001	AT	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A074447-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074447-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074447-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074447-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074447-001	AT	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
4de25cad-9156-ffae-eb2b-85736b333948	Product name	2	20201015
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
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
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
4d57173b-5512-6c00-533c-5ed2a40fc5b8	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	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
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-615-25	2019-09-24	C162847	48780-1	934fe258-483f-48b1-e053-8cdaa90a720a	Flurbiprofen Sodium Ophthalmic Solution USP, 0.03%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-615-25	Flurbiprofen Sodium	2.5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2.5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-615-25	ML - Milliliter	21695-615	bf153a68-20e8-468a-b1dc-25ae70e0d761	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Flurbiprofen Sodium	ACTIVE INGREDIENT	Z5B97MU9K4	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
FLURBIPROFEN	ACTIVE MOIETY	5GRO578KLP	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Citric Acid	INACTIVE INGREDIENT	2968PHW8QP	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Potassium Chloride	INACTIVE INGREDIENT	660YQ98I10	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Thimerosal	INACTIVE INGREDIENT	2225PI3MOV	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-615	FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20101119_725fb4ac-3bd2-4c0f-829f-a3a40863ebce.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flurbiprofen Sodium	FLURBIPROFEN SODIUM	Amici Pharma, Inc.	c27f2d57-4b9d-4b78-8d85-3bac84f733b1	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074447 application number: ANDA074447
Flurbiprofen Sodium	FLURBIPROFEN SODIUM	Bausch & Lomb Incorporated	11db354f-caf9-4567-811e-6c9beb1330c7	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074447 application number: ANDA074447
Flurbiprofen Sodium	FLURBIPROFEN SODIUM	A-S Medication Solutions	9243ed05-1f7b-43ee-82c3-572a4112ae09	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074447 application number: ANDA074447
Flurbiprofen Sodium	FLURBIPROFEN SODIUM	Proficient Rx LP	8c5247a4-6388-44f4-8a47-3de5e7c5b169	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074447 application number: ANDA074447

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
Z5B97MU9K4	FLURBIPROFEN SODIUM	FLURBIPROFEN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1243585	flurbiprofen sodium 0.03 % Ophthalmic Solution	PSN	725fb4ac-3bd2-4c0f-829f-a3a40863ebce	1
1243585	flurbiprofen sodium 0.3 MG/ML Ophthalmic Solution	SCD	725fb4ac-3bd2-4c0f-829f-a3a40863ebce	1
1243585	flurbiprofen sodium 0.03 % Ophthalmic Solution	SY	725fb4ac-3bd2-4c0f-829f-a3a40863ebce	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-615-25	21695061525	2.5 mL in 1 BOTTLE, DROPPER	2.5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flurbiprofen Sodium Ophthalmic Solution USP, 0.03%	Rebel Distributors Corp	2010-09-28	HUMAN PRESCRIPTION DRUG LABEL	1