Amlodipine and Benazepril Hydrochloride

Product NDC
0591-3761
11-digit product format
005913761
Labeler code
0591
Product ID
0591-3761_d8c10de7-f915-4dc1-a167-6729f0015ee8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA090364
Marketing category
ANDA
Marketing start
2011-07-05
Marketing end
2019-08-31
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0591-3761DDiscontinued by firm2026-10-12
excluded packagepackage0591-37610591-3761-01DDiscontinued by firm2026-10-12
excluded packagepackage0591-37610591-3761-05DDiscontinued by firm2026-10-12

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0591-3761-05DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0591-3761-01DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage0591-3761-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05
A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090364-001AB
A090364-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0584e616aacf4f…
2026-08-18 06:07:402026-07A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090364-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090364-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0574a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090364-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090364-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090364-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090364-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090364-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090364-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090364-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090364-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090364-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090364-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090364-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090364-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090364-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090364-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090364-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090364-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090364-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090364-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090364-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090364-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090364-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090364-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090364-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090364-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090364-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090364-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090364-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090364-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090364-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090364-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090364-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090364-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090364-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090364-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090364-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090364-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090364-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090364-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090364-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090364-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3761-01EA - Each0591-3761a0241484-e5a4-4969-9d19-b0b1cd8d4ec612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
GELATININACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
TALCINACTIVE INGREDIENT7SEV7J4R1UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSN37f78ade-1f5a-4ace-9908-3d1404d286061
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD37f78ade-1f5a-4ace-9908-3d1404d286061
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSY37f78ade-1f5a-4ace-9908-3d1404d286061
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSY37f78ade-1f5a-4ace-9908-3d1404d286061