CAMBIA

Product NDC: 50192-113
11-digit product format: 501920113
Labeler code: 50192
Product ID: 50192-113_3a38ddb1-2e6b-406e-8992-a1c9cbd9acd0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Potassium
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Nautilus Neurosciences, Inc.
Application: NDA022165
Marketing category: NDA
Marketing start: 2010-04-20
Marketing end: 0000-00-00
Substance: DICLOFENAC POTASSIUM
Active strength: 1 mg/mg
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50192-113		I	Inactivated by FDA	2026-08-11
excluded package	package	50192-113	50192-113-01	I	Inactivated by FDA	2026-08-11
excluded package	package	50192-113	50192-113-09	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 · 66 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	50192-113-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50192-113-09	`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	50192-113-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50192-113-09	`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	50192-113-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50192-113-09	`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	50192-113-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50192-113-09	`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	50192-113-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50192-113-09	`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	50192-113-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50192-113-09	`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	50192-113-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50192-113-09	`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	50192-113-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50192-113-09	`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	50192-113-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50192-113-09	`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	50192-113-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50192-113-09	`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	50192-113-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50192-113-09	`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	50192-113-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50192-113-09	`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	50192-113-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50192-113-09	`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	50192-113-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50192-113-09	`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	50192-113-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50192-113-09	`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	50192-113-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50192-113-09	`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	50192-113-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50192-113-09	`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	50192-113-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50192-113-09	`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	50192-113-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50192-113-09	`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	50192-113-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50192-113-09	`e2bbac7714bc…`	`27bdfed8d636…`

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
N022165-001	CAMBIA	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022165-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product
N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product
N022165-001	8927604	2026-06-16	U-436		2015-01-21
N022165-001	9827197	2026-06-16		Drug product	2017-12-05

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	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022165-001	CAMBIA	50MG	FOR SOLUTION / ORAL	AB	RLD, RS	2009-06-17	`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	N022165-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022165-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022165-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022165-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022165-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022165-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022165-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022165-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022165-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022165-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022165-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022165-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022165-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022165-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022165-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022165-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022165-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022165-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022165-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022165-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022165-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022165-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022165-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022165-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022165-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022165-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022165-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022165-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022165-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022165-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022165-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022165-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022165-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022165-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022165-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022165-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022165-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022165-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022165-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022165-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022165-001	8927604	2026-06-16	U-436		2015-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022165-001	9827197	2026-06-16		Drug product	2017-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022165-001	8927604	2026-06-16	U-436		2015-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022165-001	9827197	2026-06-16		Drug product	2017-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022165-001	8927604	2026-06-16	U-436		2015-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022165-001	9827197	2026-06-16		Drug product	2017-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022165-001	8927604	2026-06-16	U-436		2015-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022165-001	9827197	2026-06-16		Drug product	2017-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022165-001	8927604	2026-06-16	U-436		2015-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022165-001	9827197	2026-06-16		Drug product	2017-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022165-001	8927604	2026-06-16	U-436		2015-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022165-001	9827197	2026-06-16		Drug product	2017-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022165-001	8927604	2026-06-16	U-436		2015-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022165-001	9827197	2026-06-16		Drug product	2017-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022165-001	8927604	2026-06-16	U-436		2015-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022165-001	9827197	2026-06-16		Drug product	2017-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022165-001	8927604	2026-06-16	U-436		2015-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022165-001	9827197	2026-06-16		Drug product	2017-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022165-001	7759394	2026-06-16	U-436	Drug substance, Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022165-001	8097651	2026-06-16	U-436	Drug substance, Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022165-001	8927604	2026-06-16	U-436		2015-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022165-001	9827197	2026-06-16		Drug product	2017-12-05	`d06236e962d9…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50192-113-01	2019-11-13	C162847	48780-1	97449f38-c317-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use CAMBIA safely and effectively. See full prescribing information for CAMBIA. CAMBIA (Diclofenac Potassium for Oral Solution) Initial U.S. Approval: 1988
50192-113-09	2019-11-13	C162847	48780-1	97449f38-c317-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use CAMBIA safely and effectively. See full prescribing information for CAMBIA. CAMBIA (Diclofenac Potassium for Oral Solution) Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50192-113-01	CAMBIA	50 mg in 1 PACKET	POWDER, FOR SOLUTION	50	4
50192-113-09	CAMBIA	50 mg in 1 PACKET	POWDER, FOR SOLUTION	50	4
50192-113-09	CAMBIA	09 in 1 BOX	POWDER, FOR SOLUTION	09	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50192-113-01	EA - Each	50192-113	8f9336ae-b637-42d8-b9a7-4ad403ad341f	1	2012-07-24
50192-113-09	EA - Each	50192-113	5eea2156-9b90-4d86-b141-1982c5c2b6bd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC POTASSIUM	ACTIVE INGREDIENT	L4D5UA6CB4	CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [NAUTILUS NEUROSCIENCES, INC.]	4
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [NAUTILUS NEUROSCIENCES, INC.]	4
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [NAUTILUS NEUROSCIENCES, INC.]	4
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [NAUTILUS NEUROSCIENCES, INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [NAUTILUS NEUROSCIENCES, INC.]	4
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [NAUTILUS NEUROSCIENCES, INC.]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [NAUTILUS NEUROSCIENCES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50192-113	CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [NAUTILUS NEUROSCIENCES, INC.]	4	Legacy NDC, 3 package rows	20120402_d7335594-50c9-4ae2-a3e3-b9a375187b62.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
Cambia	DICLOFENAC POTASSIUM	Assertio Therapeutics, Inc.	d249ced1-4ca0-4f57-adcb-23440f58f659	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022165 application number: NDA022165
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	Leading Pharma, LLC	9dd418b2-4b0e-498c-b453-f580c69ddc6d	2024-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022165 application number: NDA022165

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L4D5UA6CB4	DICLOFENAC POTASSIUM	15307-81-0	DICLOFENAC POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
859066	CAMBIA 50 MG Powder for Oral Solution	PSN	d7335594-50c9-4ae2-a3e3-b9a375187b62	4
859063	diclofenac potassium 50 MG Powder for Oral Solution	PSN	d7335594-50c9-4ae2-a3e3-b9a375187b62	4
859066	diclofenac potassium 50 MG Powder for Oral Solution [Cambia]	SBD	d7335594-50c9-4ae2-a3e3-b9a375187b62	4
859063	diclofenac potassium 50 MG Powder for Oral Solution	SCD	d7335594-50c9-4ae2-a3e3-b9a375187b62	4
859066	Cambia 50 MG Powder for Oral Solution	SY	d7335594-50c9-4ae2-a3e3-b9a375187b62	4
859063	Diclofenac K+ 50 MG Powder for Oral Solution	SY	d7335594-50c9-4ae2-a3e3-b9a375187b62	4
859066	Diclofenac K+ 50 MG Powder for Oral Solution [Cambia]	SY	d7335594-50c9-4ae2-a3e3-b9a375187b62	4
859063	Diclofenac Pot 50 MG Powder for Oral Solution	SY	d7335594-50c9-4ae2-a3e3-b9a375187b62	4
859066	Diclofenac Pot 50 MG Powder for Oral Solution [Cambia]	SY	d7335594-50c9-4ae2-a3e3-b9a375187b62	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50192-113-01	50192011301	50 mg in 1 PACKET	50 mg	Historical
50192-113-09	50192011309	50 mg in 1 PACKET	50 mg	Historical