AMLODIPINE BESYLATE

Product NDC: 69097-128
Requested package NDC: 69097-128-05
11-digit product format: 690970128
Labeler code: 69097
Product ID: 69097-128_7cbe66f6-99fb-403f-9c6b-e4ecc7549eaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMLODIPINE BESYLATE
Dosage form: TABLET
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA077073
Marketing category: ANDA
Marketing start: 2007-09-26
Substance: AMLODIPINE BESYLATE
Active strength: 10 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077073-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26
A077073-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26
A077073-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077073-001	AB
A077073-002	AB
A077073-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077073-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-09-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077073-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-09-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077073-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-09-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A077073-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077073-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077073-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	NuCare Pharmaceuticals, Inc.	4926f00c-ee19-3e10-e054-00144ff88e88	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	d09173a1-5e3c-4c86-8c7c-15238925ef50	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb55	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	f546047f-1cc6-4bbe-a67b-b5c9815b89af	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	215e0890-0484-45e8-a731-aea53821ad8e	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	aec7618e-c9da-431f-8b6a-14aa399242f6	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	e01efe66-2f31-4261-92ca-0b41f27104da	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Northwind Health Company, LLC	0c5784b9-5542-144f-e063-6394a90a7ebc	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Northwind Health Company, LLC	03fe9ad2-3a1a-78db-e063-6294a90a2ed3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Cipla USA Inc.	5409b296-3bed-47cd-abba-9fe6f6833af6	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073 ndc (package): 69097-128-05 ndc (product): 69097-128 ndc11 (package): 69097012805
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Quallent Pharmaceuticals Health LLC	c262dedb-1d13-4447-9355-f11e1dbbfb4d	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Proficient Rx LP	410aa0a5-43cf-455c-b51d-7dfbc24eee32	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077073 application number: ANDA077073

Additional Listing Data#

Finished product: Yes
Brand name base: AMLODIPINE BESYLATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197361	Internal RxNorm lookup
308135	Internal RxNorm lookup
308136	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
5409b296-3bed-47cd-abba-9fe6f6833af6	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69097-128-05	AMLODIPINE BESYLATE	90 in 1 BOTTLE	TABLET	90		12
69097-128-15	AMLODIPINE BESYLATE	1000 in 1 BOTTLE	TABLET	1000		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-128-05	EA - Each	69097-128	8bec5807-607f-482f-a0fa-b6a4daa15b9e	1	2015-06-09
69097-128-15	EA - Each	69097-128	54959fb9-53b9-4dde-8eeb-41a528afdfe9	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]	3
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]	3
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]	3
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [DIRECTRX]	1
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [DIRECTRX]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	AMLODIPINE BESYLATE TABLET [DIRECTRX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [DIRECTRX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-128	AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]	11	Current NDC, Legacy NDC, 2 package rows	20220727_5409b296-3bed-47cd-abba-9fe6f6833af6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	215e0890-0484-45e8-a731-aea53821ad8e	15
308135	amlodipine 10 MG Oral Tablet	SCD	215e0890-0484-45e8-a731-aea53821ad8e	15
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	215e0890-0484-45e8-a731-aea53821ad8e	15
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb55	14
308135	amlodipine 10 MG Oral Tablet	SCD	a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb55	14
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb55	14
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	5409b296-3bed-47cd-abba-9fe6f6833af6	12
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	5409b296-3bed-47cd-abba-9fe6f6833af6	12
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	5409b296-3bed-47cd-abba-9fe6f6833af6	12
308135	amlodipine 10 MG Oral Tablet	SCD	5409b296-3bed-47cd-abba-9fe6f6833af6	12
308136	amlodipine 2.5 MG Oral Tablet	SCD	5409b296-3bed-47cd-abba-9fe6f6833af6	12
197361	amlodipine 5 MG Oral Tablet	SCD	5409b296-3bed-47cd-abba-9fe6f6833af6	12
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	5409b296-3bed-47cd-abba-9fe6f6833af6	12
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	5409b296-3bed-47cd-abba-9fe6f6833af6	12
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	5409b296-3bed-47cd-abba-9fe6f6833af6	12
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	7dc972ad-2866-39a9-e053-2a91aa0a62ce	8
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a	8
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a	8
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a	8
308135	amlodipine 10 MG Oral Tablet	SCD	7dc972ad-2866-39a9-e053-2a91aa0a62ce	8
308135	amlodipine 10 MG Oral Tablet	SCD	16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a	8
308136	amlodipine 2.5 MG Oral Tablet	SCD	16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a	8
197361	amlodipine 5 MG Oral Tablet	SCD	16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a	8
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a	8
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	7dc972ad-2866-39a9-e053-2a91aa0a62ce	8
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a	8
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a	8
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	b2ce9cd0-1c79-4b35-b87b-daff2c381a73	5
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	b2ce9cd0-1c79-4b35-b87b-daff2c381a73	5
308135	amlodipine 10 MG Oral Tablet	SCD	b2ce9cd0-1c79-4b35-b87b-daff2c381a73	5
197361	amlodipine 5 MG Oral Tablet	SCD	b2ce9cd0-1c79-4b35-b87b-daff2c381a73	5
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	b2ce9cd0-1c79-4b35-b87b-daff2c381a73	5
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	b2ce9cd0-1c79-4b35-b87b-daff2c381a73	5
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	6440ca1f-5377-3c18-e053-2991aa0ab012	4
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	410aa0a5-43cf-455c-b51d-7dfbc24eee32	4
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	03fe9ad2-3a1a-78db-e063-6294a90a2ed3	4
308135	amlodipine 10 MG Oral Tablet	SCD	6440ca1f-5377-3c18-e053-2991aa0ab012	4
308135	amlodipine 10 MG Oral Tablet	SCD	410aa0a5-43cf-455c-b51d-7dfbc24eee32	4
308135	amlodipine 10 MG Oral Tablet	SCD	03fe9ad2-3a1a-78db-e063-6294a90a2ed3	4
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	6440ca1f-5377-3c18-e053-2991aa0ab012	4
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	410aa0a5-43cf-455c-b51d-7dfbc24eee32	4
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	03fe9ad2-3a1a-78db-e063-6294a90a2ed3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-128-05	69097012805	90 TABLET in 1 BOTTLE (69097-128-05)	90 tablet	2007-09-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMLODIPINE BESYLATE	NuCare Pharmaceuticals, Inc.	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	7
AMLODIPINE BESYLATE	REMEDYREPACK INC.	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	15
AMLODIPINE BESYLATE	Bryant Ranch Prepack	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	15
AMLODIPINE BESYLATE	Northwind Health Company, LLC \| Northwind Health Company	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
AMLODIPINE BESYLATE	Cipla USA Inc. \| CIPLA LIMITED VIRGONAGAR \| CIPLA LIMITED GOA \| CIPLA LIMITED PATALGANGA \| CIPLA LIMITED INDORE	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	12
AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	2025-01-03	HUMAN PRESCRIPTION DRUG LABEL	10
AMLODIPINE BESYLATE	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	5
AMLODIPINE BESYLATE	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	8
AMLODIPINE BESYLATE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-11-29	HUMAN PRESCRIPTION DRUG LABEL	4
AMLODIPINE BESYLATE	DirectRX	2021-08-10	HUMAN PRESCRIPTION DRUG LABEL	5
AMLODIPINE BESYLATE	St. Mary's Medical Park Pharmacy	2020-12-14	HUMAN PRESCRIPTION DRUG LABEL	4
AMLODIPINE BESYLATE	Clinical Solutions Wholesale, LLC	2020-07-26	HUMAN PRESCRIPTION DRUG LABEL	5
AMLODIPINE BESYLATE	Proficient Rx LP	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	4
AMLODIPINE BESYLATE	medsource pharmaceuticals	2018-12-24	HUMAN PRESCRIPTION DRUG LABEL	8
AMLODIPINE BESYLATE	NCS HealthCare of KY, Inc dba Vangard Labs	2016-05-24	HUMAN PRESCRIPTION DRUG LABEL	7