Home NDC 69101-510-50 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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210045-001 CONSENSI AMLODIPINE BESYLATE; CELECOXIB EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 N210045-002 CONSENSI AMLODIPINE BESYLATE; CELECOXIB EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 N210045-003 CONSENSI AMLODIPINE BESYLATE; CELECOXIB EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210045-001 10350171 2038-06-14 Drug product 2019-09-06 N210045-002 10350171 2038-06-14 Drug product 2019-09-06 N210045-003 10350171 2038-06-14 Drug product 2019-09-06
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 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 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210045-002 CONSENSI EQ 5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210045-003 CONSENSI EQ 10MG BASE;200MG TABLET / ORAL RLD 2018-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210045-001 CONSENSI EQ 2.5MG BASE;200MG TABLET / ORAL RLD 2018-05-31 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 14 · 522 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 N210045-001 10350171 2038-06-14 Drug product 2019-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210045-002 10350171 2038-06-14 Drug product 2019-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210045-003 10350171 2038-06-14 Drug product 2019-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210045-001 10350171 2038-06-14 Drug product 2019-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210045-002 10350171 2038-06-14 Drug product 2019-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210045-003 10350171 2038-06-14 Drug product 2019-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210045-001 9662315 2029-05-22 U-2410 Drug product 2018-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-001 9408837 2030-02-28 U-2410 2020-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-001 10350171 2038-06-14 Drug product 2019-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-001 10925835 2038-06-14 U-2410 2021-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-001 10945960 2038-06-14 Drug product 2021-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-002 9662315 2029-05-22 U-2410 Drug product 2018-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-002 9408837 2030-02-28 U-2410 2020-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-002 10350171 2038-06-14 Drug product 2019-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-002 10925835 2038-06-14 U-2410 2021-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-002 10945960 2038-06-14 Drug product 2021-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-003 9662315 2029-05-22 U-2410 Drug product 2018-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-003 9408837 2030-02-28 U-2410 2020-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-003 10350171 2038-06-14 Drug product 2019-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-003 10925835 2038-06-14 U-2410 2021-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210045-003 10945960 2038-06-14 Drug product 2021-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-001 9662315 2029-05-22 U-2410 Drug product 2018-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-001 9408837 2030-02-28 U-2410 2020-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-001 10350171 2038-06-14 Drug product 2019-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-001 10925835 2038-06-14 U-2410 2021-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-001 10945960 2038-06-14 Drug product 2021-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-002 9662315 2029-05-22 U-2410 Drug product 2018-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-002 9408837 2030-02-28 U-2410 2020-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-002 10350171 2038-06-14 Drug product 2019-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-002 10925835 2038-06-14 U-2410 2021-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-002 10945960 2038-06-14 Drug product 2021-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-003 9662315 2029-05-22 U-2410 Drug product 2018-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-003 9408837 2030-02-28 U-2410 2020-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-003 10350171 2038-06-14 Drug product 2019-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-003 10925835 2038-06-14 U-2410 2021-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210045-003 10945960 2038-06-14 Drug product 2021-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210045-001 9662315 2029-05-22 U-2410 Drug product 2018-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210045-001 9408837 2030-02-28 U-2410 2020-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210045-001 10350171 2038-06-14 Drug product 2019-09-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210045-001 10925835 2038-06-14 U-2410 2021-03-22 b8a1b40f171c…
Observed Orange Book exclusivity history# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69101-510-50 69101051050 500 TABLET in 1 BOTTLE (69101-510-50) 500 tablet 2019-12-17 2022-12-31 No No Current