Amlodipine and Benazepril Hydrochloride

Product NDC: 53002-1782
11-digit product format: 530021782
Labeler code: 53002
Product ID: 53002-1782_8f774281-703e-4db6-beba-7c7ca4da8836
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine and Benazepril Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA202239
Marketing category: ANDA
Marketing start: 2012-09-05
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength: 3 mg/1; mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53002-1782		I	Inactivated by FDA		2026-08-10
excluded package	package	53002-1782	53002-1782-0	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1782-0	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1782-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1782-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1782-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1782-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1782-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1782-0	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1782-0	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1782-0	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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	Approval date
A202239-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05
A202239-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05
A202239-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05
A202239-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05
A202239-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05
A202239-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202239-001	AB
A202239-002	AB
A202239-003	AB
A202239-004	AB
A202239-005	AB
A202239-006	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	A202239-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202239-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202239-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202239-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202239-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202239-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202239-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202239-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202239-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202239-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202239-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202239-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202239-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202239-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2012-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202239-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2012-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202239-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2012-09-05	`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	A202239-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202239-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202239-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202239-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202239-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202239-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202239-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202239-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202239-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202239-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202239-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202239-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202239-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202239-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202239-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202239-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202239-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202239-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202239-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202239-004	AB	1	`2680178bc6a6…`

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
53002-1782-0	2025-01-30	C162847	48780-1	f386c649-a8e3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1995
53002-1782-0	2023-06-07	C162847	48780-1	f386c649-a8e3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1995
53002-1782-0	2023-01-30	C162847	48780-1	f386c649-a8e3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. 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
53002-1782-0	Amlodipine and Benazepril Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1782	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 1 package rows	20230609_da84991d-042f-473c-be9e-875e19ece2da.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 and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	AvKARE	fe91d607-5e1f-48e4-e053-6294a90ac522	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	b25681a9-7b0e-40f9-844e-ec4842e3713c	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	cb87f119-1598-405f-b627-eec749c8d42c	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	Northwind Health Company, LLC	f2b56630-4e3a-6f9c-e053-2a95a90a4650	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	02e233c4-48d1-456d-8fc8-f99a06ef854a	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7b5eb6bd-e953-429e-9280-07da4f7d7f47	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	1dd12925-ede8-4ad5-9309-d8c79da1cebf	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	DIRECT RX	b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	b6eb5283-8e07-47b8-b440-fe72859d8bcc	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	Rising Pharma Holdings, Inc.	03b175fc-d430-490d-b7ac-9f7a2cb1dd8b	2024-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	3de54c49-3590-4a70-9268-fa68e434d923	2024-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	30c401b5-decf-4c0c-8180-92a9b3d7d0fb	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	c870013c-e823-4233-a803-33a74f3610a8	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	Aurobindo Pharma Limited	99ed4927-9a34-4e8d-8eea-60b63c867d46	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	55bfd9ea-b474-4863-8fae-1b720d91034c	2024-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	89d8d490-3a9c-40f2-86b7-94b5101dd09a	2023-10-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	f77db79c-c998-4b63-9984-4cf245f188a7	2023-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	69a887ab-95cd-4b81-80ee-02e20eebf65b	2023-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239
Amlodipine and Benazepril Hydrochloride	AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE	Proficient Rx LP	29a0d87e-6afb-4766-9045-1963c5b0d183	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202239 application number: ANDA202239

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
898350	amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral Capsule	PSN	da84991d-042f-473c-be9e-875e19ece2da	3
898350	amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral Capsule	SCD	da84991d-042f-473c-be9e-875e19ece2da	3
898350	amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral Capsule	SY	da84991d-042f-473c-be9e-875e19ece2da	3
898350	Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral Capsule	SY	da84991d-042f-473c-be9e-875e19ece2da	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1782-0	53002178200	100 CAPSULE in 1 BOTTLE (53002-1782-0)	100 capsule	2019-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine and Benazepril Hydrochloride	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	3