Lotrel

Product NDC
0078-0406
Requested package NDC
0078-0406-05
11-digit product format
000780406
Labeler code
0078
Product ID
0078-0406_2944a0ae-9822-463a-9e58-2bb73e86e607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and benazepril hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA020364
Marketing category
NDA
Marketing start
1995-03-03
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0078-04060078-0406-05DDiscontinued by firm2026-10-16

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020364-002LOTRELAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORALRLD1995-03-03
N020364-003LOTRELAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORALRLD1995-03-03
N020364-004LOTRELAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORALRLD1995-03-03
N020364-005LOTRELAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORALRLD2002-06-20
N020364-006LOTRELAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORALRLD2006-04-11
N020364-007LOTRELAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORALRLD2006-04-11

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 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020364-002LOTRELEQ 2.5MG BASE;10MGCAPSULE / ORALRLD1995-03-03c2088c7a36db…
2026-10-15 13:18:302026-09N020364-003LOTRELEQ 5MG BASE;10MGCAPSULE / ORALRLD1995-03-03c2088c7a36db…
2026-10-15 13:18:302026-09N020364-004LOTRELEQ 5MG BASE;20MGCAPSULE / ORALRLD1995-03-03c2088c7a36db…
2026-10-15 13:18:302026-09N020364-005LOTRELEQ 10MG BASE;20MGCAPSULE / ORALRLD2002-06-20c2088c7a36db…
2026-10-15 13:18:302026-09N020364-006LOTRELEQ 10MG BASE;40MGCAPSULE / ORALRLD2006-04-11c2088c7a36db…
2026-10-15 13:18:302026-09N020364-007LOTRELEQ 5MG BASE;40MGCAPSULE / ORALRLD2006-04-11c2088c7a36db…
2026-09-14 22:38:342026-08N020364-002LOTRELEQ 2.5MG BASE;10MGCAPSULE / ORALRLD1995-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N020364-003LOTRELEQ 5MG BASE;10MGCAPSULE / ORALRLD1995-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N020364-004LOTRELEQ 5MG BASE;20MGCAPSULE / ORALRLD1995-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N020364-005LOTRELEQ 10MG BASE;20MGCAPSULE / ORALRLD2002-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N020364-006LOTRELEQ 10MG BASE;40MGCAPSULE / ORALRLD2006-04-1184e616aacf4f…
2026-09-14 22:38:342026-08N020364-007LOTRELEQ 5MG BASE;40MGCAPSULE / ORALRLD2006-04-1184e616aacf4f…
2026-08-18 06:07:402026-07N020364-002LOTRELEQ 2.5MG BASE;10MGCAPSULE / ORALRLD1995-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N020364-003LOTRELEQ 5MG BASE;10MGCAPSULE / ORALRLD1995-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N020364-004LOTRELEQ 5MG BASE;20MGCAPSULE / ORALRLD1995-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N020364-005LOTRELEQ 10MG BASE;20MGCAPSULE / ORALRLD2002-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N020364-006LOTRELEQ 10MG BASE;40MGCAPSULE / ORALRLD2006-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07N020364-007LOTRELEQ 5MG BASE;40MGCAPSULE / ORALRLD2006-04-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020364-002LOTRELEQ 2.5MG BASE;10MGCAPSULE / ORALABRLD1995-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020364-003LOTRELEQ 5MG BASE;10MGCAPSULE / ORALABRLD1995-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020364-004LOTRELEQ 5MG BASE;20MGCAPSULE / ORALABRLD1995-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020364-005LOTRELEQ 10MG BASE;20MGCAPSULE / ORALABRLD2002-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020364-006LOTRELEQ 10MG BASE;40MGCAPSULE / ORALABRLD, RS2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020364-007LOTRELEQ 5MG BASE;40MGCAPSULE / ORALABRLD2006-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-002LOTRELEQ 2.5MG BASE;10MGCAPSULE / ORALABRLD1995-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-003LOTRELEQ 5MG BASE;10MGCAPSULE / ORALABRLD1995-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-004LOTRELEQ 5MG BASE;20MGCAPSULE / ORALABRLD1995-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-005LOTRELEQ 10MG BASE;20MGCAPSULE / ORALABRLD2002-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-006LOTRELEQ 10MG BASE;40MGCAPSULE / ORALABRLD, RS2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-007LOTRELEQ 5MG BASE;40MGCAPSULE / ORALABRLD2006-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020364-002LOTRELEQ 2.5MG BASE;10MGCAPSULE / ORALABRLD1995-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020364-003LOTRELEQ 5MG BASE;10MGCAPSULE / ORALABRLD1995-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020364-004LOTRELEQ 5MG BASE;20MGCAPSULE / ORALABRLD1995-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020364-005LOTRELEQ 10MG BASE;20MGCAPSULE / ORALABRLD2002-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020364-006LOTRELEQ 10MG BASE;40MGCAPSULE / ORALABRLD, RS2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020364-007LOTRELEQ 5MG BASE;40MGCAPSULE / ORALABRLD2006-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020364-002LOTRELEQ 2.5MG BASE;10MGCAPSULE / ORALABRLD1995-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020364-003LOTRELEQ 5MG BASE;10MGCAPSULE / ORALABRLD1995-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020364-004LOTRELEQ 5MG BASE;20MGCAPSULE / ORALABRLD1995-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020364-005LOTRELEQ 10MG BASE;20MGCAPSULE / ORALABRLD2002-06-20fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 240 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020364-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020364-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020364-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020364-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020364-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020364-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020364-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020364-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020364-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020364-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020364-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020364-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020364-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020364-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020364-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020364-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020364-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020364-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020364-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020364-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020364-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020364-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020364-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020364-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020364-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020364-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020364-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020364-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020364-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020364-006AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020364-007AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020364-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020364-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020364-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020364-005AB12680178bc6a6…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0406-05Lotrel100 in 1 BOTTLECAPSULE10030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0406-05EA - Each0078-040631ef895b-78e9-44b8-b095-5e89eb1443b012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
AMLODIPINEACTIVE MOIETY1J444QC288LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
BENAZEPRILATACTIVE MOIETYJRM708L703LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
GELATININACTIVE INGREDIENT2G86QN327LLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
TALCINACTIVE INGREDIENT7SEV7J4R1ULOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]17
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
AMLODIPINEACTIVE MOIETY1J444QC288LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
BENAZEPRILATACTIVE MOIETYJRM708L703LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
GELATININACTIVE INGREDIENT2G86QN327LLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
TALCINACTIVE INGREDIENT7SEV7J4R1ULOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
AMLODIPINEACTIVE MOIETY1J444QC288LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
BENAZEPRILATACTIVE MOIETYJRM708L703LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0406LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]30Legacy NDC, 1 package rows20241122_94ae6054-b7ae-4212-a567-4f803af8f2c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN94ae6054-b7ae-4212-a567-4f803af8f2c730
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSN94ae6054-b7ae-4212-a567-4f803af8f2c730
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSN94ae6054-b7ae-4212-a567-4f803af8f2c730
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSN94ae6054-b7ae-4212-a567-4f803af8f2c730
898344Lotrel 10 MG / 20 MG Oral CapsulePSN94ae6054-b7ae-4212-a567-4f803af8f2c730
898348Lotrel 10 MG / 40 MG Oral CapsulePSN94ae6054-b7ae-4212-a567-4f803af8f2c730
898355Lotrel 5 MG / 10 MG Oral CapsulePSN94ae6054-b7ae-4212-a567-4f803af8f2c730
898358Lotrel 5 MG / 20 MG Oral CapsulePSN94ae6054-b7ae-4212-a567-4f803af8f2c730
898344amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule [Lotrel]SBD94ae6054-b7ae-4212-a567-4f803af8f2c730
898348amlodipine 10 MG / benazepril hydrochloride 40 MG Oral Capsule [Lotrel]SBD94ae6054-b7ae-4212-a567-4f803af8f2c730
898355amlodipine 5 MG / benazepril hydrochloride 10 MG Oral Capsule [Lotrel]SBD94ae6054-b7ae-4212-a567-4f803af8f2c730
898358amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule [Lotrel]SBD94ae6054-b7ae-4212-a567-4f803af8f2c730
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD94ae6054-b7ae-4212-a567-4f803af8f2c730
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD94ae6054-b7ae-4212-a567-4f803af8f2c730
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD94ae6054-b7ae-4212-a567-4f803af8f2c730
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD94ae6054-b7ae-4212-a567-4f803af8f2c730
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898344Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule [Lotrel]SY94ae6054-b7ae-4212-a567-4f803af8f2c730
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898348Amlodipine 10 MG / BZP hydrochloride 40 MG Oral Capsule [Lotrel]SY94ae6054-b7ae-4212-a567-4f803af8f2c730
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898355Amlodipine 5 MG / BZP hydrochloride 10 MG Oral Capsule [Lotrel]SY94ae6054-b7ae-4212-a567-4f803af8f2c730
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898358Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule [Lotrel]SY94ae6054-b7ae-4212-a567-4f803af8f2c730
898344Lotrel 10/20 (amlodipine / benazepril HCl) Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898344Lotrel 10/20 Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898348Lotrel 10/40 (amlodipine / benazepril) Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898348Lotrel 10/40 Oral TabletSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898355Lotrel 5/10 (amlodipine / benazepril HCl) Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898355Lotrel 5/10 Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898358Lotrel 5/20 (amlodipine / benazepril HCl) Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898358Lotrel 5/20 Oral CapsuleSY94ae6054-b7ae-4212-a567-4f803af8f2c730
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898350amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898344Lotrel 10 MG / 20 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898348Lotrel 10 MG / 40 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898355Lotrel 5 MG / 10 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898358Lotrel 5 MG / 20 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898361Lotrel 5 MG / 40 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898344amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898348amlodipine 10 MG / benazepril hydrochloride 40 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898352amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898355amlodipine 5 MG / benazepril hydrochloride 10 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898358amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898361amlodipine 5 MG / benazepril hydrochloride 40 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898350amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898350amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898344Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898348Amlodipine 10 MG / BZP hydrochloride 40 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898350Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898352Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898355Amlodipine 5 MG / BZP hydrochloride 10 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898358Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898361Amlodipine 5 MG / BZP hydrochloride 40 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898344Lotrel 10/20 (amlodipine / benazepril HCl) Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898344Lotrel 10/20 Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898348Lotrel 10/40 (amlodipine / benazepril) Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0406-0500078040605100 CAPSULE in 1 BOTTLE (0078-0406-05) 100 capsule1995-03-030000-00-00NoNoCurrent