Application 022348

Type: NDA
Sponsor: CUMBERLAND PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALDOLOR	IBUPROFEN	SOLUTION;INTRAVENOUS	400MG/4ML (100MG/ML)	No	No
002	CALDOLOR	IBUPROFEN	SOLUTION;INTRAVENOUS	800MG/8ML (100MG/ML)	Yes	Yes
003	CALDOLOR	IBUPROFEN	SOLUTION;INTRAVENOUS	800MG/200ML (4MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022348-001	CALDOLOR	IBUPROFEN	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11
N022348-002	CALDOLOR	IBUPROFEN	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11
N022348-003	CALDOLOR	IBUPROFEN	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022348-002	8735452	2029-09-30	U-981	2014-06-04
N022348-002	8871810	2029-09-30	U-981	2014-11-12
N022348-002	9114068	2029-09-30	U-1735	2015-09-18
N022348-002	9138404	2029-09-30	U-1756	2015-10-27
N022348-002	9295639	2029-09-30	U-1756	2016-05-02
N022348-002	9649284	2029-09-30	U-2018	2017-06-09
N022348-002	9012508	2030-09-14	U-981	2015-05-04
N022348-002	11806400	2032-03-16	U-3746	2023-11-16
N022348-003	8735452	2029-09-30	U-981	2019-09-23
N022348-003	8871810	2029-09-30	U-981	2019-09-23
N022348-003	9012508	2030-09-14	U-981	2019-09-23
N022348-003	11806400	2032-03-16	U-3746	2023-11-16
N022348-003	9072661	2032-03-16	U-2264	2019-09-04
N022348-003	9072710	2032-03-16	U-2266	2019-09-10

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022348-001	NPP	2026-05-11
N022348-002	NPP	2026-05-11
N022348-003	NPP	2026-05-11

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022348-002	CALDOLOR	800MG/8ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022348-003	CALDOLOR	800MG/200ML (4MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022348-001	CALDOLOR	400MG/4ML (100MG/ML)	SOLUTION / INTRAVENOUS		2009-06-11	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 568 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022348-002	8735452	2029-09-30	U-981	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-002	8871810	2029-09-30	U-981	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-002	9114068	2029-09-30	U-1735	2015-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-002	9138404	2029-09-30	U-1756	2015-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-002	9295639	2029-09-30	U-1756	2016-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-002	9649284	2029-09-30	U-2018	2017-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-002	9012508	2030-09-14	U-981	2015-05-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-002	11806400	2032-03-16	U-3746	2023-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-003	8735452	2029-09-30	U-981	2019-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-003	8871810	2029-09-30	U-981	2019-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-003	9012508	2030-09-14	U-981	2019-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-003	11806400	2032-03-16	U-3746	2023-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-003	9072661	2032-03-16	U-2264	2019-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022348-003	9072710	2032-03-16	U-2266	2019-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022348-002	8735452	2029-09-30	U-981	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-002	8871810	2029-09-30	U-981	2014-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-002	9114068	2029-09-30	U-1735	2015-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-002	9138404	2029-09-30	U-1756	2015-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-002	9295639	2029-09-30	U-1756	2016-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-002	9649284	2029-09-30	U-2018	2017-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-002	9012508	2030-09-14	U-981	2015-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-002	11806400	2032-03-16	U-3746	2023-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-003	8735452	2029-09-30	U-981	2019-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-003	8871810	2029-09-30	U-981	2019-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-003	9012508	2030-09-14	U-981	2019-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-003	11806400	2032-03-16	U-3746	2023-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-003	9072661	2032-03-16	U-2264	2019-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022348-003	9072710	2032-03-16	U-2266	2019-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022348-002	8735452	2029-09-30	U-981	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-002	8871810	2029-09-30	U-981	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-002	9114068	2029-09-30	U-1735	2015-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-002	9138404	2029-09-30	U-1756	2015-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-002	9295639	2029-09-30	U-1756	2016-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-002	9649284	2029-09-30	U-2018	2017-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-002	9012508	2030-09-14	U-981	2015-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-002	11806400	2032-03-16	U-3746	2023-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-003	8735452	2029-09-30	U-981	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-003	8871810	2029-09-30	U-981	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-003	9012508	2030-09-14	U-981	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022348-003	11806400	2032-03-16	U-3746	2023-11-16	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N022348-001	M-128	2024-11-19	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022348-002	M-128	2024-11-19	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022348-003	M-128	2024-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022348-001	M-128	2024-11-19	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022348-002	M-128	2024-11-19	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022348-003	M-128	2024-11-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022348-001	M-128	2024-11-19	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022348-002	M-128	2024-11-19	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022348-003	M-128	2024-11-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022348-001	NPP	2026-05-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022348-002	NPP	2026-05-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022348-003	NPP	2026-05-11	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Caldolor	IBUPROFEN	Cumberland Pharmaceuticals Inc.	1eaa7790-f1a1-4f51-b10a-cbbaf033f684	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022348 application number: NDA022348 ndc (product): 66220-284 ndc (product): 66220-287

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66220-284	Caldolor	ibuprofen	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-284	Caldolor	ibuprofen	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-284	Caldolor	ibuprofen	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-287	Caldolor	ibuprofen	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-287	Caldolor	ibuprofen	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-287	Caldolor	ibuprofen	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-287	Caldolor	ibuprofen	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-287	Caldolor	ibuprofen	Cumberland Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84846	SUPPL	2026-01-28
84834	SUPPL	2026-01-26
80390	SUPPL	2024-11-25
80308	SUPPL	2024-11-22
74232	SUPPL	2023-05-12
72828	SUPPL	2022-12-08
72814	SUPPL	2022-12-07
69386	SUPPL	2021-11-23
69364	SUPPL	2021-11-22
67333	SUPPL	2021-05-03
67274	SUPPL	2021-04-30
59424	SUPPL	2019-07-23
59418	SUPPL	2019-07-23
38607	SUPPL	2016-05-11
29633	SUPPL	2016-05-11
17280	SUPPL	2015-11-25
7278	SUPPL	2015-11-23
7277	SUPPL	2015-01-28
42496	ORIG	2010-03-11
24286	ORIG	2010-03-11
38606	ORIG	2009-06-22
29632	ORIG	2009-06-17
51171	SUPPL	1900-01-01
51170	SUPPL	1900-01-01
51169	SUPPL	1900-01-01
51168	SUPPL	1900-01-01