Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
55111-586
Requested package NDC
55111-586-01
11-digit product format
551110586
Labeler code
55111
Product ID
55111-586_2b57e667-c854-2ed1-32f9-b06c6fea1930
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA090149
Marketing category
ANDA
Marketing start
2011-07-05
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
10; 40 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 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.

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 HYDROCHLORIDE40 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
898346Internal 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
f12f18bb-7ddb-e7dc-4edd-32f4ac212bcaAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
55111-586-01Amlodipine Besylate and Benazepril Hydrochloride100 in 1 BOTTLECAPSULE10014
55111-586-05Amlodipine Besylate and Benazepril Hydrochloride500 in 1 BOTTLECAPSULE50014
55111-586-30Amlodipine Besylate and Benazepril Hydrochloride30 in 1 BOTTLECAPSULE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-586-01EA - Each55111-5862bf363ae-04d4-4048-8248-617175a02a3b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
crospovidoneINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
gelatinINACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
TalcINACTIVE INGREDIENT7SEV7J4R1UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]8
amlodipine besylateACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
amlodipine besylateACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
benazepril hydrochlorideACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
benazepril hydrochlorideACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
BENAZEPRILACTIVE MOIETYUDM7Q7QWP8AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
crospovidoneINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
crospovidoneINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-586AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]14Current NDC, Legacy NDC, 3 package rows20221224_f12f18bb-7ddb-e7dc-4edd-32f4ac212bca.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 · 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
ndc (package): 55111-586-01
ndc (product): 55111-586
ndc11 (package): 55111058601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSNf12f18bb-7ddb-e7dc-4edd-32f4ac212bca14
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSNf12f18bb-7ddb-e7dc-4edd-32f4ac212bca14
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCDf12f18bb-7ddb-e7dc-4edd-32f4ac212bca14
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCDf12f18bb-7ddb-e7dc-4edd-32f4ac212bca14
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSYf12f18bb-7ddb-e7dc-4edd-32f4ac212bca14
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSYf12f18bb-7ddb-e7dc-4edd-32f4ac212bca14
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSYf12f18bb-7ddb-e7dc-4edd-32f4ac212bca14
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSYf12f18bb-7ddb-e7dc-4edd-32f4ac212bca14
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSN15f7cde7-8dc2-4b07-83a9-9b86d6ec7f431
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSNc95fe9f4-fb64-41b1-a61f-85b102d099291
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSN15f7cde7-8dc2-4b07-83a9-9b86d6ec7f431
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD15f7cde7-8dc2-4b07-83a9-9b86d6ec7f431
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCDc95fe9f4-fb64-41b1-a61f-85b102d099291
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD15f7cde7-8dc2-4b07-83a9-9b86d6ec7f431
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSYc95fe9f4-fb64-41b1-a61f-85b102d099291
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSY15f7cde7-8dc2-4b07-83a9-9b86d6ec7f431
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSY15f7cde7-8dc2-4b07-83a9-9b86d6ec7f431
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSYc95fe9f4-fb64-41b1-a61f-85b102d099291
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSY15f7cde7-8dc2-4b07-83a9-9b86d6ec7f431
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSY15f7cde7-8dc2-4b07-83a9-9b86d6ec7f431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-586-0155111058601100 CAPSULE in 1 BOTTLE (55111-586-01) 100 capsule2011-07-050000-00-00NoNoCurrent