Amlodipine and Benazepril Hydrochloride

Product NDC
57237-143
11-digit product format
572370143
Labeler code
57237
Product ID
57237-143_a4aff76f-e9a9-4300-b42c-616d8ca55d5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202239
Marketing category
ANDA
Marketing start
2012-09-05
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5; 10 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
A202239-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2012-09-05
A202239-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2012-09-05
A202239-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2012-09-05
A202239-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2012-09-05
A202239-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2012-09-05
A202239-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2012-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202239-001AB
A202239-002AB
A202239-003AB
A202239-004AB
A202239-005AB
A202239-006AB

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 UTC2026-02A202239-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2012-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202239-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2012-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202239-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2012-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202239-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2012-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202239-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2012-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202239-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2012-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2012-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2012-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2012-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2012-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2012-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2012-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202239-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2012-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202239-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2012-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202239-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2012-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202239-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2012-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202239-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2012-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202239-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2012-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2012-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2012-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2012-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2012-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2012-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2012-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2012-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2012-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2012-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2012-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2012-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2012-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2012-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2012-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2012-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2012-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2012-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALAB2012-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202239-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2012-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202239-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2012-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202239-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2012-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202239-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALAB2012-09-052680178bc6a6…

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 UTC2026-02A202239-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202239-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202239-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202239-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202239-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202239-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202239-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202239-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202239-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202239-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202239-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202239-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202239-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202239-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202239-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202239-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202239-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202239-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202239-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202239-004AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
BENAZEPRIL HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
898342Internal RxNorm lookup
898346Internal RxNorm lookup
898350Internal RxNorm lookup
898353Internal RxNorm lookup
898356Internal RxNorm lookup
898359Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03b175fc-d430-490d-b7ac-9f7a2cb1dd8bAvailable 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
57237-143-01Amlodipine and Benazepril Hydrochloride100 in 1 BOTTLECAPSULE1009
57237-143-05Amlodipine and Benazepril Hydrochloride500 in 1 BOTTLECAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-143-01EA - Each57237-14363ff4fd3-04e9-42bb-859f-745b21f92ccb12016-01-13
57237-143-05EA - Each57237-143d79398dd-9de2-4dd1-af02-0755207b560512016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-143AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 2 package rows20240913_03b175fc-d430-490d-b7ac-9f7a2cb1dd8b.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 and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEAvKAREfe91d607-5e1f-48e4-e053-6294a90ac5222026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.b25681a9-7b0e-40f9-844e-ec4842e3713c2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.cb87f119-1598-405f-b627-eec749c8d42c2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCf2b56630-4e3a-6f9c-e053-2a95a90a46502026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.02e233c4-48d1-456d-8fc8-f99a06ef854a2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7b5eb6bd-e953-429e-9280-07da4f7d7f472025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions1dd12925-ede8-4ad5-9309-d8c79da1cebf2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7192025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsb6eb5283-8e07-47b8-b440-fe72859d8bcc2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDERising Pharma Holdings, Inc.03b175fc-d430-490d-b7ac-9f7a2cb1dd8b2024-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
ndc (product): 57237-143
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack3de54c49-3590-4a70-9268-fa68e434d9232024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack30c401b5-decf-4c0c-8180-92a9b3d7d0fb2024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackc870013c-e823-4233-a803-33a74f3610a82024-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEAurobindo Pharma Limited99ed4927-9a34-4e8d-8eea-60b63c867d462024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions55bfd9ea-b474-4863-8fae-1b720d91034c2024-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions89d8d490-3a9c-40f2-86b7-94b5101dd09a2023-10-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsf77db79c-c998-4b63-9984-4cf245f188a72023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions69a887ab-95cd-4b81-80ee-02e20eebf65b2023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEProficient Rx LP29a0d87e-6afb-4766-9045-1963c5b0d1832022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202239
application number: ANDA202239

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSN03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898350amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral CapsulePSN03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSN03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSN03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSN03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898350amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898350amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898350Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSY03b175fc-d430-490d-b7ac-9f7a2cb1dd8b9
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSN89d8d490-3a9c-40f2-86b7-94b5101dd09a8
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD89d8d490-3a9c-40f2-86b7-94b5101dd09a8
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSY89d8d490-3a9c-40f2-86b7-94b5101dd09a8
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSY89d8d490-3a9c-40f2-86b7-94b5101dd09a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-143-0157237014301100 CAPSULE in 1 BOTTLE (57237-143-01) 100 capsule2012-09-050000-00-00NoNoCurrent
57237-143-0557237014305500 CAPSULE in 1 BOTTLE (57237-143-05) 500 capsule2012-09-050000-00-00NoNoCurrent