Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
50090-1463
Requested package NDC
50090-1463-0
11-digit product format
500901463
Labeler code
50090
Product ID
50090-1463_2d73d3ea-82e4-4f17-bc0f-9102cec17877
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090149
Marketing category
ANDA
Marketing start
2011-07-05
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
10 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
2022-12-31
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 packagepackage50090-146350090-1463-0DDiscontinued by firm2026-10-05

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 · 11 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…

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
A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05
A090149-002AMLODIPINE 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
A090149-001AB
A090149-002AB

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 22:38:342026-08A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0584e616aacf4f…
2026-08-18 06:07:402026-07A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090149-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090149-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090149-002AMLODIPINE 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 22:38:342026-08A090149-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090149-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090149-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090149-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090149-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090149-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090149-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090149-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090149-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090149-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090149-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090149-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090149-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090149-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090149-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090149-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090149-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090149-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090149-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090149-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090149-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090149-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090149-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090149-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090149-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090149-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090149-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090149-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090149-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090149-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090149-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090149-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090149-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090149-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090149-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090149-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090149-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090149-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090149-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090149-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1463-0EA - Each50090-14632c3829e8-f4b9-48fc-8bfd-fb1e6ac0f8fc12018-10-11

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.2542895b-c8f8-4f21-9e12-f5a7fe17f9052026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090149
application number: ANDA090149
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedf12f18bb-7ddb-e7dc-4edd-32f4ac212bca2022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090149
application number: ANDA090149

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1463-05009014630090 CAPSULE in 1 BOTTLE (50090-1463-0) 90 capsule2014-11-280000-00-00NoNoCurrent