Amlodipine Besylate

Product NDC: 57664-055
11-digit product format: 576640055
Labeler code: 57664
Product ID: 57664-055_8858588a-91db-42f1-89fe-9a70b1bc369d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMLODIPINE BESYLATE
Dosage form: TABLET
Route: ORAL
Labeler: Caraco Pharmaceutical Laboratories, Ltd.
Application: ANDA078552
Marketing category: ANDA
Marketing start: 2012-10-19
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE
Active strength: 3 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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
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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57664-055-13	2019-11-27	C162847	48780-1	9855d018-db32-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987
57664-055-18	2019-11-27	C162847	48780-1	9855d018-db32-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987
57664-055-99	2019-11-27	C162847	48780-1	9855d018-db32-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57664-055-13	Amlodipine Besylate	500 in 1 BOTTLE	TABLET	500	2
57664-055-18	Amlodipine Besylate	1000 in 1 BOTTLE	TABLET	1000	2
57664-055-99	Amlodipine Besylate	90 in 1 BOTTLE	TABLET	90	2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-055-13	EA - Each	57664-055	0ea3641a-fb1a-4227-b86d-8159a6247f11	1	2013-02-13
57664-055-18	EA - Each	57664-055	eca4885b-ff20-40a9-a532-36fff00b8d30	1	2013-02-13
57664-055-99	EA - Each	57664-055	b75661cb-4d4c-4cd4-b78d-452a0fe4541b	1	2013-02-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	2
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-055	AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	2	Legacy NDC, 3 package rows	20121109_42881d5b-7e35-496e-aeeb-8da760d4267c.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	42881d5b-7e35-496e-aeeb-8da760d4267c	2
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	42881d5b-7e35-496e-aeeb-8da760d4267c	2
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	42881d5b-7e35-496e-aeeb-8da760d4267c	2
308135	amlodipine 10 MG Oral Tablet	SCD	42881d5b-7e35-496e-aeeb-8da760d4267c	2
308136	amlodipine 2.5 MG Oral Tablet	SCD	42881d5b-7e35-496e-aeeb-8da760d4267c	2
197361	amlodipine 5 MG Oral Tablet	SCD	42881d5b-7e35-496e-aeeb-8da760d4267c	2
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	42881d5b-7e35-496e-aeeb-8da760d4267c	2
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	42881d5b-7e35-496e-aeeb-8da760d4267c	2
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	42881d5b-7e35-496e-aeeb-8da760d4267c	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
57664-055-13	57664005513	500 in 1 BOTTLE	Historical
57664-055-18	57664005518	1000 in 1 BOTTLE	Historical
57664-055-99	57664005599	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine Besylate	Caraco Pharmaceutical Laboratories, Ltd. \| Epic Pharma, LLC	2012-11-08	HUMAN PRESCRIPTION DRUG LABEL	2