AMLODIPINE BESYLATE

Product NDC: 71093-146
11-digit product format: 710930146
Labeler code: 71093
Product ID: 71093-146_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: 2.5 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

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71093-146-03	AMLODIPINE BESYLATE	90 in 1 BOTTLE	TABLET	90		5
71093-146-05	AMLODIPINE BESYLATE	500 in 1 BOTTLE	TABLET	500		5

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71093-146-03	EA - Each	71093-146	ae2adecb-dca8-480a-853d-a75b74c604a6	1	2018-12-13
71093-146-05	EA - Each	71093-146	bec32c04-d19a-4fb9-8894-5f70133c8f40	1	2018-12-13

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71093-146	AMLODIPINE BESYLATE TABLET [ACI HEALTHCARE USA, INC.]	5	Current NDC, Legacy NDC, 2 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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71093-146-03	71093014603	90 TABLET in 1 BOTTLE (71093-146-03)	90 tablet	2018-11-12	0000-00-00	No	No	Current
71093-146-05	71093014605	500 TABLET in 1 BOTTLE (71093-146-05)	500 tablet	2018-11-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMLODIPINE BESYLATE	ACI Healthcare USA, Inc. \| VIVIMED LIFE SCIENCES PRIVATE LIMITED	2022-12-30	HUMAN PRESCRIPTION DRUG LABEL	5