Consensi

Product NDC
69101-510
Requested package NDC
69101-510-50
11-digit product format
691010510
Labeler code
69101
Product ID
69101-510_cbf55cb0-be42-efa2-e053-2995a90a2a09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and celecoxib
Dosage form
TABLET
Route
ORAL
Labeler
Burke Therapeutics, LLC
Application
NDA210045
Marketing category
NDA
Marketing start
2019-12-17
Marketing end
2022-12-31
Substance
AMLODIPINE BESYLATE; CELECOXIB
Active strength
10 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69101-51069101-510-50DDiscontinued 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
N210045-001CONSENSIAMLODIPINE BESYLATE; CELECOXIBEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-31
N210045-002CONSENSIAMLODIPINE BESYLATE; CELECOXIBEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-31
N210045-003CONSENSIAMLODIPINE BESYLATE; CELECOXIBEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-31

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210045-001103501712038-06-14Drug product2019-09-06
N210045-002103501712038-06-14Drug product2019-09-06
N210045-003103501712038-06-14Drug product2019-09-06

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 UTC2026-02N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210045-002CONSENSIEQ 5MG BASE;200MGTABLET / ORALRLD2018-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210045-003CONSENSIEQ 10MG BASE;200MGTABLET / ORALRLD2018-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210045-001CONSENSIEQ 2.5MG BASE;200MGTABLET / ORALRLD2018-05-318072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 14 · 522 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210045-001103501712038-06-14Drug product2019-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210045-002103501712038-06-14Drug product2019-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210045-003103501712038-06-14Drug product2019-09-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210045-001103501712038-06-14Drug product2019-09-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210045-002103501712038-06-14Drug product2019-09-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210045-003103501712038-06-14Drug product2019-09-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N210045-00196623152029-05-22U-2410Drug product2018-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-00194088372030-02-28U-24102020-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-001103501712038-06-14Drug product2019-09-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-001109258352038-06-14U-24102021-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-001109459602038-06-14Drug product2021-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-00296623152029-05-22U-2410Drug product2018-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-00294088372030-02-28U-24102020-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-002103501712038-06-14Drug product2019-09-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-002109258352038-06-14U-24102021-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-002109459602038-06-14Drug product2021-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-00396623152029-05-22U-2410Drug product2018-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-00394088372030-02-28U-24102020-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-003103501712038-06-14Drug product2019-09-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-003109258352038-06-14U-24102021-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210045-003109459602038-06-14Drug product2021-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-00196623152029-05-22U-2410Drug product2018-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-00194088372030-02-28U-24102020-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-001103501712038-06-14Drug product2019-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-001109258352038-06-14U-24102021-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-001109459602038-06-14Drug product2021-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-00296623152029-05-22U-2410Drug product2018-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-00294088372030-02-28U-24102020-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-002103501712038-06-14Drug product2019-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-002109258352038-06-14U-24102021-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-002109459602038-06-14Drug product2021-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-00396623152029-05-22U-2410Drug product2018-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-00394088372030-02-28U-24102020-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-003103501712038-06-14Drug product2019-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-003109258352038-06-14U-24102021-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210045-003109459602038-06-14Drug product2021-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210045-00196623152029-05-22U-2410Drug product2018-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210045-00194088372030-02-28U-24102020-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210045-001103501712038-06-14Drug product2019-09-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210045-001109258352038-06-14U-24102021-03-22b8a1b40f171c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N210045-001NC2021-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N210045-002NC2021-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N210045-003NC2021-05-3174a2ff9319b5…
2021-12-28 21:50 UTC2021-12N210045-001NC2021-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12N210045-002NC2021-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12N210045-003NC2021-05-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210045-001NC2021-05-3187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210045-002NC2021-05-3187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210045-003NC2021-05-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N210045-001NC2021-05-315aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N210045-002NC2021-05-315aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N210045-003NC2021-05-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210045-001NC2021-05-318869cabd3fbd…
2020-12-22 03:56 UTC2020-12N210045-002NC2021-05-318869cabd3fbd…
2020-12-22 03:56 UTC2020-12N210045-003NC2021-05-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210045-001NC2021-05-31c0c555d07b60…
2020-11-12 02:37 UTC2020-11N210045-002NC2021-05-31c0c555d07b60…
2020-11-12 02:37 UTC2020-11N210045-003NC2021-05-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210045-001NC2021-05-313f01610625f2…
2019-12-14 00:12 UTC2019-12N210045-002NC2021-05-313f01610625f2…
2019-12-14 00:12 UTC2019-12N210045-003NC2021-05-313f01610625f2…
2019-09-15 20:21 UTC2019-09N210045-001NC2021-05-31b00525d2431f…
2019-09-15 20:21 UTC2019-09N210045-002NC2021-05-31b00525d2431f…
2019-09-15 20:21 UTC2019-09N210045-003NC2021-05-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N210045-001NC2021-05-31ea99ee380514…
2019-07-19 19:46 UTC2019-07N210045-002NC2021-05-31ea99ee380514…
2019-07-19 19:46 UTC2019-07N210045-003NC2021-05-31ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69101-510-30EA - Each69101-5107e6c5dff-ef16-4ff4-a105-fa64e7ae9ccd12020-01-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69101-510-5069101051050500 TABLET in 1 BOTTLE (69101-510-50) 500 tablet2019-12-172022-12-31NoNoCurrent