Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
55111-339
11-digit product format
551110339
Labeler code
55111
Product ID
55111-339_6fafdf6a-6153-9a62-1774-755f2bcf0cc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA077183
Marketing category
ANDA
Marketing start
2010-04-19
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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-15
A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-15
A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-15
A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A077183-001AB
A077183-002AB
A077183-003AB
A077183-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-1584e616aacf4f…
2026-09-14 22:38:342026-08A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-1584e616aacf4f…
2026-09-14 22:38:342026-08A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-1584e616aacf4f…
2026-09-14 22:38:342026-08A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-1584e616aacf4f…
2026-08-18 06:07:402026-07A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALAB2010-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALAB2010-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALAB2010-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALAB2010-04-155bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077183-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077183-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077183-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077183-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A077183-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077183-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077183-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077183-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077183-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077183-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077183-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077183-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077183-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077183-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077183-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077183-004AB15bbf6a4d5a75…

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 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
864V2Q084HInternal UNII lookup
N1SN99T69TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca014f06-982c-6fe1-9948-a3701dd35d34Available 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
55111-339-01Amlodipine Besylate and Benazepril Hydrochloride100 in 1 BOTTLECAPSULE10016
55111-339-05Amlodipine Besylate and Benazepril Hydrochloride500 in 1 BOTTLECAPSULE50016
55111-339-30Amlodipine Besylate and Benazepril Hydrochloride30 in 1 BOTTLECAPSULE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-339-01EA - Each55111-339455d0c6b-5826-4ae3-8fb9-8c211fcfab0b12012-07-24
55111-339-05EA - Each55111-33980c95478-767a-46f8-98cb-9c89560ef49d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
crospovidoneINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
gelatinINACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
BENAZEPRILACTIVE MOIETYUDM7Q7QWP8AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
crospovidoneINACTIVE INGREDIENT68401960MKAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
gelatinINACTIVE INGREDIENT2G86QN327LAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-339AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]16Current NDC, Legacy NDC, 3 package rows20221224_ca014f06-982c-6fe1-9948-a3701dd35d34.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCfa153720-b24c-60d0-e053-6294a90a97d52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077183
application number: ANDA077183
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC106c08c2-90eb-6bc0-e063-6294a90a5a232025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077183
application number: ANDA077183
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions7a75935a-31af-4571-b7d9-8c297a635b572025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077183
application number: ANDA077183
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedca014f06-982c-6fe1-9948-a3701dd35d342022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077183
application number: ANDA077183
ndc (product): 55111-339

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSNca014f06-982c-6fe1-9948-a3701dd35d3416
898350amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral CapsulePSNca014f06-982c-6fe1-9948-a3701dd35d3416
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSNca014f06-982c-6fe1-9948-a3701dd35d3416
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSNca014f06-982c-6fe1-9948-a3701dd35d3416
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDca014f06-982c-6fe1-9948-a3701dd35d3416
898350amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCDca014f06-982c-6fe1-9948-a3701dd35d3416
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCDca014f06-982c-6fe1-9948-a3701dd35d3416
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDca014f06-982c-6fe1-9948-a3701dd35d3416
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898350amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898350Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSNb8237631-4bb5-4b7a-8439-6fdef2cbe0232
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCDb8237631-4bb5-4b7a-8439-6fdef2cbe0232
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSYb8237631-4bb5-4b7a-8439-6fdef2cbe0232
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSYb8237631-4bb5-4b7a-8439-6fdef2cbe0232
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSN13ecf91f-dce8-4262-a54a-7bef2b1591c31
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSN241e7477-ecae-4f84-8410-bbfaa9f57ed01
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSN4da56a43-99aa-46df-aafc-ea193c46e4421
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD13ecf91f-dce8-4262-a54a-7bef2b1591c31
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD241e7477-ecae-4f84-8410-bbfaa9f57ed01
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD4da56a43-99aa-46df-aafc-ea193c46e4421
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSY13ecf91f-dce8-4262-a54a-7bef2b1591c31
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSY4da56a43-99aa-46df-aafc-ea193c46e4421
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSY241e7477-ecae-4f84-8410-bbfaa9f57ed01
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSY13ecf91f-dce8-4262-a54a-7bef2b1591c31
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSY241e7477-ecae-4f84-8410-bbfaa9f57ed01
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSY4da56a43-99aa-46df-aafc-ea193c46e4421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-339-0155111033901100 CAPSULE in 1 BOTTLE (55111-339-01) 100 capsule2010-04-190000-00-00NoNoCurrent
55111-339-0555111033905500 CAPSULE in 1 BOTTLE (55111-339-05) 500 capsule2010-04-190000-00-00NoNoCurrent
55111-339-305511103393030 CAPSULE in 1 BOTTLE (55111-339-30) 30 capsule2010-04-190000-00-00NoNoCurrent