AMLODIPINE BESYLATE

Product NDC: 71093-148
11-digit product format: 710930148
Labeler code: 71093
Product ID: 71093-148_5a93579c-5d45-4662-b39c-8d93b04f52dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMLODIPINE BESYLATE
Dosage form: TABLET
Route: ORAL
Labeler: ACI Healthcare USA, Inc.
Application: ANDA077516
Marketing category: ANDA
Marketing start: 2011-04-15
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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71093-148		D	Discontinued by firm	2026-09-14
excluded package	package	71093-148	71093-148-03	D	Discontinued by firm	2026-09-14
excluded package	package	71093-148	71093-148-05	D	Discontinued by firm	2026-09-14
excluded package	package	71093-148	71093-148-06	D	Discontinued by firm	2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077516-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-11
A077516-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-11
A077516-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-11

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 4 · 129 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
2026-09-14 22:38:34	2026-08	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL		2007-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2007-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2007-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL		2007-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2007-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2007-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A077516-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077516-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077516-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077516-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077516-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077516-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077516-001	AB	1	`8072bd15b7f6…`

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	SPL version
71093-148-03	AMLODIPINE BESYLATE	90 in 1 BOTTLE	TABLET	90	5
71093-148-05	AMLODIPINE BESYLATE	500 in 1 BOTTLE	TABLET	500	5
71093-148-06	AMLODIPINE BESYLATE	1000 in 1 BOTTLE	TABLET	1000	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71093-148-03	EA - Each	71093-148	8b764307-080f-4b78-a955-49febd58ed09	1	2018-12-13
71093-148-06	EA - Each	71093-148	e4a8822d-c2f0-4053-b47c-30e1a5587318	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71093-148	AMLODIPINE BESYLATE TABLET [ACI HEALTHCARE USA, INC.]	5	Current NDC, Legacy NDC, 3 package rows	20221231_b431dceb-a3d3-4d53-9d0f-c6a452c584d7.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	cb3da88f-cee0-4c22-9760-a50edc8fc140	102
308135	amlodipine 10 MG Oral Tablet	SCD	cb3da88f-cee0-4c22-9760-a50edc8fc140	102
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	cb3da88f-cee0-4c22-9760-a50edc8fc140	102
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	b431dceb-a3d3-4d53-9d0f-c6a452c584d7	5
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	b431dceb-a3d3-4d53-9d0f-c6a452c584d7	5
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	b431dceb-a3d3-4d53-9d0f-c6a452c584d7	5
308135	amlodipine 10 MG Oral Tablet	SCD	b431dceb-a3d3-4d53-9d0f-c6a452c584d7	5
308136	amlodipine 2.5 MG Oral Tablet	SCD	b431dceb-a3d3-4d53-9d0f-c6a452c584d7	5
197361	amlodipine 5 MG Oral Tablet	SCD	b431dceb-a3d3-4d53-9d0f-c6a452c584d7	5
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	b431dceb-a3d3-4d53-9d0f-c6a452c584d7	5
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	b431dceb-a3d3-4d53-9d0f-c6a452c584d7	5
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	b431dceb-a3d3-4d53-9d0f-c6a452c584d7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71093-148-03	71093014803	90 TABLET in 1 BOTTLE (71093-148-03)	90 tablet	2018-11-12	0000-00-00	No	No	Current
71093-148-05	71093014805	500 TABLET in 1 BOTTLE (71093-148-05)	500 tablet	2018-11-12	0000-00-00	No	No	Current
71093-148-06	71093014806	1000 TABLET in 1 BOTTLE (71093-148-06)	1000 tablet	2018-11-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMLODIPINE BESYLATE	Bryant Ranch Prepack	2023-03-27	HUMAN PRESCRIPTION DRUG LABEL	102
AMLODIPINE BESYLATE	ACI Healthcare USA, Inc. \| VIVIMED LIFE SCIENCES PRIVATE LIMITED	2022-12-30	HUMAN PRESCRIPTION DRUG LABEL	5
AMLODIPINE BESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	2022-05-09	HUMAN PRESCRIPTION DRUG LABEL	4