Amlodipine Besylate and Benazepril Hydrochloride

Product NDC: 71335-1946
11-digit product format: 713351946
Labeler code: 71335
Product ID: 71335-1946_fc9bf21b-3d41-4224-a476-0a07fee74859
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate and Benazepril Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078466
Marketing category: ANDA
Marketing start: 2018-08-01
Substance: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength: 5; 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
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB		2010-02-05
A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB		2010-02-05
A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB		2010-02-05
A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB		2010-02-05
A078466-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB		2011-07-05
A078466-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RS	2011-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078466-001	AB
A078466-002	AB
A078466-003	AB
A078466-004	AB
A078466-005	AB
A078466-006	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A078466-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078466-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amlodipine Besylate and Benazepril Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	5 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
864V2Q084H	Internal UNII lookup
N1SN99T69T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
898356	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
f16e04b5-57b9-49cc-811b-07d85ccb5d9f	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1946-1	Amlodipine Besylate and Benazepril Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	102
71335-1946-2	Amlodipine Besylate and Benazepril Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	102
71335-1946-3	Amlodipine Besylate and Benazepril Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	102
71335-1946-4	Amlodipine Besylate and Benazepril Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1946	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	101	Current NDC, Legacy NDC, 4 package rows	20240509_f16e04b5-57b9-49cc-811b-07d85ccb5d9f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	c695f95d-6064-4a22-84ba-c8e62477b3a7	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	318b3273-e8f7-416c-b371-10c56fa8e0fd	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5f7a4bd1-8083-46ca-95f2-e8c476b5367c	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ff807933-7433-4f8c-9d09-02a57e51d0fc	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	f16e04b5-57b9-49cc-811b-07d85ccb5d9f	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466 ndc (product): 71335-1946
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	4e6bf47a-ee8a-4083-8cce-a6a25260d3fb	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	ea774c36-e970-4d9c-9487-6cc57741fec5	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	5813e6b6-f524-4fba-99ba-9f4e365bf523	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	c56a384c-b250-4a43-99ce-ddd88376c817	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	3b13554a-0f63-4238-8f55-a1400c847c9f	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	2b0e3752-c54e-4c50-9640-1a6fefa6dec5	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	3ad66075-0875-4703-9d21-a424b5ab892a	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	c9693ad5-0fa6-4796-b20b-2021d589a132	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	968c611b-43a7-40f0-9ed3-aa67ee88364b	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	dc206611-5188-40a6-b025-61db41f68a5a	2025-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	0f253cac-67ac-4b03-b1a8-f2c345938dda	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	d058e426-8786-4fd3-a771-992e4558c135	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	7c75fa72-9b0f-44bf-a745-dfa647ed1e78	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	BluePoint Laboratories	df8e23c8-6c8f-4293-8a37-5ad3d48dba94	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466

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
898356	amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral Capsule	PSN	f16e04b5-57b9-49cc-811b-07d85ccb5d9f	102
898356	amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule	SCD	f16e04b5-57b9-49cc-811b-07d85ccb5d9f	102
898356	amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral Capsule	SY	f16e04b5-57b9-49cc-811b-07d85ccb5d9f	102
898356	Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule	SY	f16e04b5-57b9-49cc-811b-07d85ccb5d9f	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1946-1	71335194601	30 CAPSULE in 1 BOTTLE (71335-1946-1)	30 capsule	2021-09-21	0000-00-00	No	No	Current
71335-1946-2	71335194602	90 CAPSULE in 1 BOTTLE (71335-1946-2)	90 capsule	2021-09-21	0000-00-00	No	No	Current
71335-1946-3	71335194603	60 CAPSULE in 1 BOTTLE (71335-1946-3)	60 capsule	2021-09-21	0000-00-00	No	No	Current
71335-1946-4	71335194604	100 CAPSULE in 1 BOTTLE (71335-1946-4)	100 capsule	2021-09-21		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine Besylate and Benazepril Hydrochloride	Bryant Ranch Prepack	2026-03-06	HUMAN PRESCRIPTION DRUG LABEL	102