Lotrel

Product NDC: 0078-0364
11-digit product format: 000780364
Labeler code: 0078
Product ID: 0078-0364_b9db75d9-9d1e-4b2d-9876-5f5520feaecc
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: 2026-09-30
Substance: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength: 10; 20 mg/1; mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag: No
Current FDA listing: Yes

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0078-0364	0078-0364-05	D	Discontinued by firm		2026-08-03

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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020364-002	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	RLD	1995-03-03
N020364-003	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	RLD	1995-03-03
N020364-004	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	RLD	1995-03-03
N020364-005	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	RLD	2002-06-20
N020364-006	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	RLD	2006-04-11
N020364-007	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	RLD	2006-04-11

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 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`2680178bc6a6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020364-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020364-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-005	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lotrel

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1
BENAZEPRIL HYDROCHLORIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N1SN99T69T	Internal UNII lookup
864V2Q084H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
898342	Internal RxNorm lookup
898344	Internal RxNorm lookup
898346	Internal RxNorm lookup
898348	Internal RxNorm lookup
898353	Internal RxNorm lookup
898355	Internal RxNorm lookup
898356	Internal RxNorm lookup
898358	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
94ae6054-b7ae-4212-a567-4f803af8f2c7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0078-0364-05	2023-08-01	C162847	48780-1	0191ceaa-6f09-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use LOTREL safely and effectively. See full prescribing information for LOTREL. LOTREL (amlodipine and benazepril hydrochloride) capsules, for oral use Initial U.S. Approval: 1995
0078-0364-05	2023-07-28	C162847	48780-1	0191ceaa-6f09-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use LOTREL safely and effectively. See full prescribing information for LOTREL. LOTREL (amlodipine and benazepril hydrochloride) capsules, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0078-0364-05	Lotrel	100 in 1 BOTTLE	CAPSULE	100		30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0364-05	EA - Each	0078-0364	0dc4bf8d-918f-4bee-9d34-8cbfa0a104a6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
BENAZEPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	N1SN99T69T	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
AMLODIPINE	ACTIVE MOIETY	1J444QC288	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
BENAZEPRILAT	ACTIVE MOIETY	JRM708L703	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
CALCIUM PHOSPHATE	INACTIVE INGREDIENT	97Z1WI3NDX	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	17
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
BENAZEPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	N1SN99T69T	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
AMLODIPINE	ACTIVE MOIETY	1J444QC288	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
BENAZEPRILAT	ACTIVE MOIETY	JRM708L703	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
CALCIUM PHOSPHATE	INACTIVE INGREDIENT	97Z1WI3NDX	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0364	LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	30	Current NDC, Legacy NDC, 1 package rows	20241122_94ae6054-b7ae-4212-a567-4f803af8f2c7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lotrel	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	94ae6054-b7ae-4212-a567-4f803af8f2c7	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020364 application number: NDA020364 ndc (product): 0078-0364

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
N1SN99T69T	BENAZEPRIL HYDROCHLORIDE	86541-74-4	BENAZEPRIL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
898342	amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral Capsule	PSN	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898346	amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral Capsule	PSN	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898353	amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral Capsule	PSN	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898356	amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral Capsule	PSN	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898344	Lotrel 10 MG / 20 MG Oral Capsule	PSN	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898348	Lotrel 10 MG / 40 MG Oral Capsule	PSN	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898355	Lotrel 5 MG / 10 MG Oral Capsule	PSN	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898358	Lotrel 5 MG / 20 MG Oral Capsule	PSN	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898344	amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule [Lotrel]	SBD	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898348	amlodipine 10 MG / benazepril hydrochloride 40 MG Oral Capsule [Lotrel]	SBD	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898355	amlodipine 5 MG / benazepril hydrochloride 10 MG Oral Capsule [Lotrel]	SBD	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898358	amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule [Lotrel]	SBD	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898342	amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule	SCD	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898346	amlodipine 10 MG / benazepril hydrochloride 40 MG Oral Capsule	SCD	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898353	amlodipine 5 MG / benazepril hydrochloride 10 MG Oral Capsule	SCD	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898356	amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule	SCD	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898346	amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898342	amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898353	amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898356	amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898342	Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898344	Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule [Lotrel]	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898346	Amlodipine 10 MG / BZP hydrochloride 40 MG Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898348	Amlodipine 10 MG / BZP hydrochloride 40 MG Oral Capsule [Lotrel]	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898353	Amlodipine 5 MG / BZP hydrochloride 10 MG Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898355	Amlodipine 5 MG / BZP hydrochloride 10 MG Oral Capsule [Lotrel]	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898356	Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898358	Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule [Lotrel]	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898344	Lotrel 10/20 (amlodipine / benazepril HCl) Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898344	Lotrel 10/20 Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898348	Lotrel 10/40 (amlodipine / benazepril) Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898348	Lotrel 10/40 Oral Tablet	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898355	Lotrel 5/10 (amlodipine / benazepril HCl) Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898355	Lotrel 5/10 Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898358	Lotrel 5/20 (amlodipine / benazepril HCl) Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898358	Lotrel 5/20 Oral Capsule	SY	94ae6054-b7ae-4212-a567-4f803af8f2c7	30
898342	amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898346	amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898350	amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898353	amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898356	amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898359	amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898344	Lotrel 10 MG / 20 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898348	Lotrel 10 MG / 40 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898355	Lotrel 5 MG / 10 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898358	Lotrel 5 MG / 20 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898361	Lotrel 5 MG / 40 MG Oral Capsule	PSN	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898344	amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule [Lotrel]	SBD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898348	amlodipine 10 MG / benazepril hydrochloride 40 MG Oral Capsule [Lotrel]	SBD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898352	amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral Capsule [Lotrel]	SBD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898355	amlodipine 5 MG / benazepril hydrochloride 10 MG Oral Capsule [Lotrel]	SBD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898358	amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule [Lotrel]	SBD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898361	amlodipine 5 MG / benazepril hydrochloride 40 MG Oral Capsule [Lotrel]	SBD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898342	amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule	SCD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898346	amlodipine 10 MG / benazepril hydrochloride 40 MG Oral Capsule	SCD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898350	amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral Capsule	SCD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898353	amlodipine 5 MG / benazepril hydrochloride 10 MG Oral Capsule	SCD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898356	amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule	SCD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898359	amlodipine 5 MG / benazepril hydrochloride 40 MG Oral Capsule	SCD	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898346	amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898342	amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898350	amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898353	amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898356	amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898359	amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898342	Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898344	Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule [Lotrel]	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898346	Amlodipine 10 MG / BZP hydrochloride 40 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898348	Amlodipine 10 MG / BZP hydrochloride 40 MG Oral Capsule [Lotrel]	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898350	Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898352	Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral Capsule [Lotrel]	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898353	Amlodipine 5 MG / BZP hydrochloride 10 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898355	Amlodipine 5 MG / BZP hydrochloride 10 MG Oral Capsule [Lotrel]	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898356	Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898358	Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule [Lotrel]	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898359	Amlodipine 5 MG / BZP hydrochloride 40 MG Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898361	Amlodipine 5 MG / BZP hydrochloride 40 MG Oral Capsule [Lotrel]	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898344	Lotrel 10/20 (amlodipine / benazepril HCl) Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898344	Lotrel 10/20 Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3
898348	Lotrel 10/40 (amlodipine / benazepril) Oral Capsule	SY	4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0364-05	00078036405	100 CAPSULE in 1 BOTTLE (0078-0364-05)	100 capsule	1995-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lotrel	Novartis Pharmaceuticals Corporation	2023-08-01	HUMAN PRESCRIPTION DRUG LABEL	30
Lotrel	Physicians Total Care, Inc.	2012-03-02	HUMAN PRESCRIPTION DRUG LABEL	3