Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
50090-6427
Requested package NDC
50090-6427-0
11-digit product format
500906427
Labeler code
50090
Product ID
50090-6427_323f987f-059b-466e-abc1-e133b0393c01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078466
Marketing category
ANDA
Marketing start
2018-08-01
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
10; 20 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine Besylate and Benazepril Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1
BENAZEPRIL HYDROCHLORIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864V2Q084HInternal UNII lookup
N1SN99T69TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
898342Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9693ad5-0fa6-4796-b20b-2021d589a132Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6427-0Amlodipine Besylate and Benazepril Hydrochloride30 in 1 BOTTLECAPSULE303
50090-6427-1Amlodipine Besylate and Benazepril Hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6427-0EA - Each50090-64271fd0c568-6404-4562-95aa-53660f8a8f5412023-05-05
50090-6427-1EA - Each50090-64271dd6bc57-a503-4147-b295-f31176d01e8312023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6427AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230418_c9693ad5-0fa6-4796-b20b-2021d589a132.zip

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
ndc (package): 50090-6427-0
ndc (product): 50090-6427
ndc11 (package): 50090642700
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSNc9693ad5-0fa6-4796-b20b-2021d589a1323
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDc9693ad5-0fa6-4796-b20b-2021d589a1323
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSYc9693ad5-0fa6-4796-b20b-2021d589a1323
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSYc9693ad5-0fa6-4796-b20b-2021d589a1323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6427-05009064270030 CAPSULE in 1 BOTTLE (50090-6427-0) 30 capsule2023-04-07NoNoCurrent