Home NDC 66220-284 Caldolor
Product NDC 66220-284
11-digit product format 662200284
Labeler code 66220
Product ID 66220-284_42d97e40-3617-496a-96e7-d95cbd530bc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ibuprofen
Dosage form INJECTION
Route INTRAVENOUS
Labeler Cumberland Pharmaceuticals Inc.
Application NDA022348
Marketing category NDA
Marketing start 2020-01-01
Substance IBUPROFEN
Active strength 800 mg/200mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing 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.
Additional Listing Data#
Finished product Yes
Brand name base Caldolor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 800 mg/200mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 854183 Internal RxNorm lookup 854187 Internal RxNorm lookup 2178273 Internal RxNorm lookup 2178275 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66220-284-11 Caldolor 200 mL in 1 BAG INJECTION 200 16 66220-284-22 Caldolor 20 in 1 CASE INJECTION 20 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66220-284 CALDOLOR (IBUPROFEN) INJECTION [CUMBERLAND PHARMACEUTICALS INC.] 16 Current NDC, Legacy NDC, 2 package rows 20250216_1eaa7790-f1a1-4f51-b10a-cbbaf033f684.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 · 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 2025-02-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022348 application number: NDA022348 ndc (product): 66220-284
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66220-284-11 66220028411 200 mL in 1 BAG 200 ml Historical 66220-284-22 66220028422 20 BAG in 1 CASE (66220-284-22) / 200 mL in 1 BAG (66220-284-11) 20 bag 2020-01-01 0000-00-00 No No Current