FDA.reportPublic FDA data

Caldolor

Product NDC
66220-287
11-digit product format
662200287
Labeler code
66220
Product ID
66220-287_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
2009-06-11
Substance
IBUPROFEN
Active strength
800 mg/8mL
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66220-28766220-287-24DDiscontinued by firm2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022348-001CALDOLORIBUPROFEN400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-11
N022348-002CALDOLORIBUPROFEN800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-11
N022348-003CALDOLORIBUPROFEN800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-25

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022348-00287354522029-09-30U-9812014-06-04
N022348-00288718102029-09-30U-9812014-11-12
N022348-00291140682029-09-30U-17352015-09-18
N022348-00291384042029-09-30U-17562015-10-27
N022348-00292956392029-09-30U-17562016-05-02
N022348-00296492842029-09-30U-20182017-06-09
N022348-00290125082030-09-14U-9812015-05-04
N022348-002118064002032-03-16U-37462023-11-16
N022348-00387354522029-09-30U-9812019-09-23
N022348-00388718102029-09-30U-9812019-09-23
N022348-00390125082030-09-14U-9812019-09-23
N022348-003118064002032-03-16U-37462023-11-16
N022348-00390726612032-03-16U-22642019-09-04
N022348-00390727102032-03-16U-22662019-09-10

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N022348-001NPP2026-05-11
N022348-002NPP2026-05-11
N022348-003NPP2026-05-11

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022348-002CALDOLOR800MG/8ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2009-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022348-003CALDOLOR800MG/200ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-01-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022348-001CALDOLOR400MG/4ML (100MG/ML)SOLUTION / INTRAVENOUS2009-06-118072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 14 · 540 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022348-00287354522029-09-30U-9812014-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00288718102029-09-30U-9812014-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00291140682029-09-30U-17352015-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00291384042029-09-30U-17562015-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00292956392029-09-30U-17562016-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00296492842029-09-30U-20182017-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00290125082030-09-14U-9812015-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-002118064002032-03-16U-37462023-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00387354522029-09-30U-9812019-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00388718102029-09-30U-9812019-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00390125082030-09-14U-9812019-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-003118064002032-03-16U-37462023-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00390726612032-03-16U-22642019-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-00390727102032-03-16U-22662019-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00287354522029-09-30U-9812014-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00288718102029-09-30U-9812014-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00291140682029-09-30U-17352015-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00291384042029-09-30U-17562015-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00292956392029-09-30U-17562016-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00296492842029-09-30U-20182017-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00290125082030-09-14U-9812015-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-002118064002032-03-16U-37462023-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00387354522029-09-30U-9812019-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00388718102029-09-30U-9812019-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00390125082030-09-14U-9812019-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-003118064002032-03-16U-37462023-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00390726612032-03-16U-22642019-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-00390727102032-03-16U-22662019-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022348-00287354522029-09-30U-9812014-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-00288718102029-09-30U-9812014-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-00291140682029-09-30U-17352015-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-00291384042029-09-30U-17562015-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-00292956392029-09-30U-17562016-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-00296492842029-09-30U-20182017-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-00290125082030-09-14U-9812015-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-002118064002032-03-16U-37462023-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-00387354522029-09-30U-9812019-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-00388718102029-09-30U-9812019-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-00390125082030-09-14U-9812019-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-003118064002032-03-16U-37462023-11-166a471c1ec25d…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N022348-001NPP2026-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-002NPP2026-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022348-003NPP2026-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-001NPP2026-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-002NPP2026-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022348-003NPP2026-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022348-001NPP2026-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-002NPP2026-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022348-003NPP2026-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022348-001NPP2026-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022348-002NPP2026-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022348-003NPP2026-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022348-001NPP2026-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022348-002NPP2026-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022348-003NPP2026-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022348-001M-1282024-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022348-001NPP2026-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022348-002M-1282024-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022348-002NPP2026-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022348-003M-1282024-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022348-003NPP2026-05-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022348-001M-1282024-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022348-001NPP2026-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022348-002M-1282024-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022348-002NPP2026-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022348-003M-1282024-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022348-003NPP2026-05-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022348-001M-1282024-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022348-001NPP2026-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022348-002M-1282024-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022348-002NPP2026-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022348-003M-1282024-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022348-003NPP2026-05-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022348-001M-1282024-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022348-001NPP2026-05-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022348-002M-1282024-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022348-002NPP2026-05-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022348-003M-1282024-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022348-003NPP2026-05-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022348-001M-1282024-11-19d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Caldolor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN800 mg/8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854183Internal RxNorm lookup
854187Internal RxNorm lookup
2178273Internal RxNorm lookup
2178275Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1eaa7790-f1a1-4f51-b10a-cbbaf033f684Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66220-287-08Caldolor25 in 1 CARTONINJECTION2516
66220-287-08Caldolor8 mL in 1 VIALINJECTION816
66220-287-11Caldolor200 mL in 1 BAGINJECTION20016
66220-287-24Caldolor20 in 1 CASEINJECTION2016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66220-287-08ML - Milliliter66220-28702e1f770-1a7b-482c-905b-5f393ce1f40d12012-07-24
66220-287-24ML - Milliliter66220-287d1ea4f13-7750-402f-a7c6-5a7ae0d5c11f12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66220-287CALDOLOR (IBUPROFEN) INJECTION [CUMBERLAND PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 4 package rows20250216_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CaldolorIBUPROFENCumberland Pharmaceuticals Inc.1eaa7790-f1a1-4f51-b10a-cbbaf033f6842025-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022348
application number: NDA022348
ndc (product): 66220-287

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2178275Caldolor 800 MG in 200 ML InjectionPSN1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
854187Caldolor 800 MG in 8 ML InjectionPSN1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
2178273ibuprofen 800 MG in 200 ML InjectionPSN1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
854183ibuprofen 800 MG in 8 ML InjectionPSN1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
2178275200 ML ibuprofen 4 MG/ML Injection [Caldolor]SBD1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
8541878 ML ibuprofen 100 MG/ML Injection [Caldolor]SBD1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
2178273200 ML ibuprofen 4 MG/ML InjectionSCD1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
8541838 ML ibuprofen 100 MG/ML InjectionSCD1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
2178275200 ML Caldolor 4 MG/ML InjectionSY1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
8541878 ML Caldolor 100 MG/ML InjectionSY1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
2178275Caldolor 800 MG per 200 ML InjectionSY1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
854187Caldolor 800 MG per 8 ML InjectionSY1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
2178273ibuprofen 800 MG per 200 ML InjectionSY1eaa7790-f1a1-4f51-b10a-cbbaf033f68416
854183ibuprofen 800 MG per 8 ML InjectionSY1eaa7790-f1a1-4f51-b10a-cbbaf033f68416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66220-287-086622002870825 VIAL in 1 CARTON (66220-287-08) / 8 mL in 1 VIAL25 vial2009-06-110000-00-00NoNoCurrent
66220-287-1166220028711200 mL in 1 BAG200 mlHistorical
66220-287-246622002872420 in 1 CASEHistorical