Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
70934-560
11-digit product format
709340560
Labeler code
70934
Product ID
70934-560_ac261a69-df51-8b36-e053-2995a90a8746
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA078466
Marketing category
ANDA
Marketing start
2020-02-24
Marketing end
0000-00-00
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
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-560DDiscontinued by firm2026-08-03
excluded packagepackage70934-56070934-560-30DDiscontinued by firm2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-560-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-560-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-560-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-560-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-560-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-560-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-560-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-560-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70934-560-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70934-560-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70934-560-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70934-560-30557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078466-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-02-05
A078466-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-02-05
A078466-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-02-05
A078466-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-02-05
A078466-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05
A078466-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALABRS2011-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A078466-001AB
A078466-002AB
A078466-003AB
A078466-004AB
A078466-005AB
A078466-006AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078466-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078466-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078466-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078466-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078466-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078466-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078466-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078466-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078466-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078466-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078466-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078466-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2011-07-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2011-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078466-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078466-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078466-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078466-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-02-052680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078466-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078466-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078466-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078466-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078466-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078466-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078466-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078466-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078466-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078466-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078466-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078466-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078466-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078466-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078466-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078466-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078466-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078466-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078466-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078466-004AB12680178bc6a6…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsc695f95d-6064-4a22-84ba-c8e62477b3a72026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack318b3273-e8f7-416c-b371-10c56fa8e0fd2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5f7a4bd1-8083-46ca-95f2-e8c476b5367c2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ff807933-7433-4f8c-9d09-02a57e51d0fc2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackf16e04b5-57b9-49cc-811b-07d85ccb5d9f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack4e6bf47a-ee8a-4083-8cce-a6a25260d3fb2026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.ea774c36-e970-4d9c-9487-6cc57741fec52026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack5813e6b6-f524-4fba-99ba-9f4e365bf5232026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackc56a384c-b250-4a43-99ce-ddd88376c8172026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions3b13554a-0f63-4238-8f55-a1400c847c9f2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions2b0e3752-c54e-4c50-9640-1a6fefa6dec52025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions3ad66075-0875-4703-9d21-a424b5ab892a2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsc9693ad5-0fa6-4796-b20b-2021d589a1322025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELupin Pharmaceuticals, Inc.968c611b-43a7-40f0-9ed3-aa67ee88364b2025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.dc206611-5188-40a6-b025-61db41f68a5a2025-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.0f253cac-67ac-4b03-b1a8-f2c345938dda2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackd058e426-8786-4fd3-a771-992e4558c1352025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.7c75fa72-9b0f-44bf-a745-dfa647ed1e782025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBluePoint Laboratoriesdf8e23c8-6c8f-4293-8a37-5ad3d48dba942023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078466
application number: ANDA078466

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-560-307093405603030 CAPSULE in 1 BOTTLE, PLASTIC (70934-560-30) 30 capsule2020-02-240000-00-00NoNoCurrent