Amlodipine Besylate and Benazepril Hydrochloride

Product NDC: 0781-2273
11-digit product format: 007812273
Labeler code: 0781
Product ID: 0781-2273_ee885922-cc1f-4cf5-89ff-43714520d1fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate and benazepril hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Sandoz Inc
Application: NDA020364
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1995-03-03
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength: 5 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: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
0781-2273-01	2021-12-24	C162847	48780-1	9d75b9d1-19f5-f424-e053-dadaa90a57ce	6d0c2df4-e9db-4622-95e8-33aa8a08f593
0781-2273-10	2021-12-24	C162847	48780-1	9d75b9d1-19f5-f424-e053-dadaa90a57ce	6d0c2df4-e9db-4622-95e8-33aa8a08f593
0781-2273-01	2020-01-31	C162847	48780-1	9d75b9d1-19f5-f424-e053-dadaa90a57ce	6d0c2df4-e9db-4622-95e8-33aa8a08f593
0781-2273-10	2020-01-31	C162847	48780-1	9d75b9d1-19f5-f424-e053-dadaa90a57ce	6d0c2df4-e9db-4622-95e8-33aa8a08f593

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-2273-01	EA - Each	0781-2273	94c6e226-5c5d-446d-95cd-946e4c240bae	1	2012-07-24
0781-2273-10	EA - Each	0781-2273	d5696b36-aab8-487a-9c8f-d86db6fe3cc3	1	2012-07-24
0781-2273-64	EA - Each	0781-2273	c8d40c1a-5786-49a4-bf77-fa5577eca085	1	2013-02-11

DailyMed Socrata Ingredients#

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

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	1c20ce12-06d3-4060-9936-ea847a525053	2
898346	amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral Capsule	PSN	1c20ce12-06d3-4060-9936-ea847a525053	2
898350	amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral Capsule	PSN	1c20ce12-06d3-4060-9936-ea847a525053	2
898353	amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral Capsule	PSN	1c20ce12-06d3-4060-9936-ea847a525053	2
898356	amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral Capsule	PSN	f40161f0-7b9e-4131-92d6-893cb9473e71	2
898356	amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral Capsule	PSN	1c20ce12-06d3-4060-9936-ea847a525053	2
898359	amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral Capsule	PSN	1c20ce12-06d3-4060-9936-ea847a525053	2
898342	amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule	SCD	1c20ce12-06d3-4060-9936-ea847a525053	2
898346	amlodipine 10 MG / benazepril hydrochloride 40 MG Oral Capsule	SCD	1c20ce12-06d3-4060-9936-ea847a525053	2
898350	amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral Capsule	SCD	1c20ce12-06d3-4060-9936-ea847a525053	2
898353	amlodipine 5 MG / benazepril hydrochloride 10 MG Oral Capsule	SCD	1c20ce12-06d3-4060-9936-ea847a525053	2
898356	amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule	SCD	f40161f0-7b9e-4131-92d6-893cb9473e71	2
898356	amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule	SCD	1c20ce12-06d3-4060-9936-ea847a525053	2
898359	amlodipine 5 MG / benazepril hydrochloride 40 MG Oral Capsule	SCD	1c20ce12-06d3-4060-9936-ea847a525053	2
898346	amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898342	amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898350	amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898353	amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898356	amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898356	amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral Capsule	SY	f40161f0-7b9e-4131-92d6-893cb9473e71	2
898359	amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898342	Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898346	Amlodipine 10 MG / BZP hydrochloride 40 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898350	Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898353	Amlodipine 5 MG / BZP hydrochloride 10 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898356	Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2
898356	Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule	SY	f40161f0-7b9e-4131-92d6-893cb9473e71	2
898359	Amlodipine 5 MG / BZP hydrochloride 40 MG Oral Capsule	SY	1c20ce12-06d3-4060-9936-ea847a525053	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine Besylate and Benazepril Hydrochloride	Clinical Solutions Wholesale	2013-08-12	HUMAN PRESCRIPTION DRUG LABEL	2
Amlodipine Besylate and Benazepril Hydrochloride	Carilion Materials Management	2012-10-10	HUMAN PRESCRIPTION DRUG LABEL	2

Amlodipine Besylate and Benazepril Hydrochloride

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#