Amlodipine Besylate

Product NDC: 67544-993
11-digit product format: 675440993
Labeler code: 67544
Product ID: 67544-993_59f698be-ad3d-4c46-b99a-e381c7b4100d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076418
Marketing category: ANDA
Marketing start: 2005-10-03
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE
Active strength: 10 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-993		D	Discontinued by firm	2026-07-31
excluded package	package	67544-993	67544-993-15	D	Discontinued by firm	2026-07-31
excluded package	package	67544-993	67544-993-30	D	Discontinued by firm	2026-07-31
excluded package	package	67544-993	67544-993-45	D	Discontinued by firm	2026-07-31
excluded package	package	67544-993	67544-993-60	D	Discontinued by firm	2026-07-31

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076418-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03
A076418-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03
A076418-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-993-30	EA - Each	67544-993	3649941b-01d3-4f44-b948-fc2dc169ebde	1	2017-12-14
67544-993-45	EA - Each	67544-993	c1fa441b-c7d6-4c85-ac20-96f1208b6f43	1	2017-12-14
67544-993-60	EA - Each	67544-993	0c19d718-c517-4fd1-b696-a5d7f374bfc1	1	2017-12-14

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine Besylate	Aphena Pharma Solutions - Tennessee, LLC	2017-11-22	HUMAN PRESCRIPTION DRUG LABEL	1