Home Applications 022348 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 1 .
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 TE codes 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.
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 · 123 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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022348-002 CALDOLOR 800MG/8ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-06-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022348-003 CALDOLOR 800MG/200ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022348-001 CALDOLOR 400MG/4ML (100MG/ML) SOLUTION / INTRAVENOUS 2009-06-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022348-002 CALDOLOR 800MG/8ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-06-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022348-003 CALDOLOR 800MG/200ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022348-001 CALDOLOR 400MG/4ML (100MG/ML) SOLUTION / INTRAVENOUS 2009-06-11 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 14 · 540 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 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…2026-02-19 14:30 UTC 2026-02 N022348-003 9072661 2032-03-16 U-2264 2019-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022348-003 9072710 2032-03-16 U-2266 2019-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-002 8735452 2029-09-30 U-981 2014-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-002 8871810 2029-09-30 U-981 2014-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-002 9114068 2029-09-30 U-1735 2015-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-002 9138404 2029-09-30 U-1756 2015-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-002 9295639 2029-09-30 U-1756 2016-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-002 9649284 2029-09-30 U-2018 2017-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-002 9012508 2030-09-14 U-981 2015-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-002 11806400 2032-03-16 U-3746 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-003 8735452 2029-09-30 U-981 2019-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-003 8871810 2029-09-30 U-981 2019-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-003 9012508 2030-09-14 U-981 2019-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-003 11806400 2032-03-16 U-3746 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-003 9072661 2032-03-16 U-2264 2019-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022348-003 9072710 2032-03-16 U-2266 2019-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022348-002 8735452 2029-09-30 U-981 2014-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-002 8871810 2029-09-30 U-981 2014-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-002 9114068 2029-09-30 U-1735 2015-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-002 9138404 2029-09-30 U-1756 2015-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-002 9295639 2029-09-30 U-1756 2016-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-002 9649284 2029-09-30 U-2018 2017-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-002 9012508 2030-09-14 U-981 2015-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-002 11806400 2032-03-16 U-3746 2023-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-003 8735452 2029-09-30 U-981 2019-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-003 8871810 2029-09-30 U-981 2019-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-003 9012508 2030-09-14 U-981 2019-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022348-003 11806400 2032-03-16 U-3746 2023-11-16 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 126 observed states.
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.
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