FDA.reportPublic FDA data

Matzim LA

Product NDC
52544-695
11-digit product format
525440695
Labeler code
52544
Product ID
52544-695_6b586f35-6eb1-488c-839e-581f695d3f07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA077686
Marketing category
ANDA
Marketing start
2011-03-28
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
420 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Matzim LA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE420 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830877, 830879, 830882, 830897, 830900, 1091623, 1091629, 1091632, 1091635, 1091638

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61ebbccf-eedf-453b-940e-dba67b7a5fefProduct name420260107
a8d6eaa3-afcc-47e5-be12-0c9251fc8740Product name120251124
f6700316-a6ba-5e59-3413-8ede05ae58b9Product name720250625
8615f7a1-1e8f-8281-8601-d7a637926d1fProduct name420250522
3a9daa2f-bcd1-13de-a1b4-6172caa7f308Product name220240419
f7129636-cba8-86c2-8bfb-9e2e2a9c7628Product name220240314
378290be-e30f-0e68-1201-165e93c337e8Product name320231212
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52544-695-10Matzim LA1000 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE100013
52544-695-19Matzim LA90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9013
52544-695-30Matzim LA30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52544-695-19EA - Each52544-695022c1fd8-c903-4605-949a-9cbd93350b8e12012-07-24
52544-695-30EA - Each52544-6955e635aeb-87cb-423a-8a8c-986065a9e26412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
DILTIAZEMACTIVE MOIETYEE92BBP03HMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19MATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
NONOXYNOL-100INACTIVE INGREDIENTA906T4D368MATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554MATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673MATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52544-695MATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]10Current NDC, Legacy NDC, 3 package rows20250406_e8c8dd18-9d95-4068-9762-bec1eb1bc25c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830877dilTIAZem hydrochloride 180 MG 24HR Extended Release Oral TabletPSNe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
830879dilTIAZem hydrochloride 240 MG 24HR Extended Release Oral TabletPSNe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
830882dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral TabletPSNe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
830897dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral TabletPSNe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
830900dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral TabletPSNe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
1091632Matzim LA 180 MG 24HR Extended Release Oral TabletPSNe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
1091629Matzim LA 240 MG 24HR Extended Release Oral TabletPSNe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
1091635Matzim LA 300 MG 24HR Extended Release Oral TabletPSNe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
1091638Matzim LA 360 MG 24HR Extended Release Oral TabletPSNe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
1091623Matzim LA 420 MG 24HR Extended Release Oral TabletPSNe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
109163224 HR diltiazem hydrochloride 180 MG Extended Release Oral Tablet [Matzim]SBDe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
109162924 HR diltiazem hydrochloride 240 MG Extended Release Oral Tablet [Matzim]SBDe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
109163524 HR diltiazem hydrochloride 300 MG Extended Release Oral Tablet [Matzim]SBDe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
109163824 HR diltiazem hydrochloride 360 MG Extended Release Oral Tablet [Matzim]SBDe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
109162324 HR diltiazem hydrochloride 420 MG Extended Release Oral Tablet [Matzim]SBDe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
83087724 HR diltiazem hydrochloride 180 MG Extended Release Oral TabletSCDe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
83087924 HR diltiazem hydrochloride 240 MG Extended Release Oral TabletSCDe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
83088224 HR diltiazem hydrochloride 300 MG Extended Release Oral TabletSCDe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
83089724 HR diltiazem hydrochloride 360 MG Extended Release Oral TabletSCDe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
83090024 HR diltiazem hydrochloride 420 MG Extended Release Oral TabletSCDe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
109163224 HR Matzim 180 MG Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
109162924 HR Matzim 240 MG Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
109163524 HR Matzim 300 MG Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
109163824 HR Matzim 360 MG Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
109162324 HR Matzim 420 MG Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
830877diltiazem hydrochloride 180 MG 24 HR Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
830879diltiazem hydrochloride 240 MG 24 HR Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
830882diltiazem hydrochloride 300 MG 24 HR Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
830897diltiazem hydrochloride 360 MG 24 HR Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
830900diltiazem hydrochloride 420 MG 24 HR Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
1091632Matzim LA 180 MG 24 HR Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
1091629Matzim LA 240 MG 24 HR Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
1091635Matzim LA 300 MG 24 HR Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
1091638Matzim LA 360 MG 24 HR Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13
1091623Matzim LA 420 MG 24 HR Extended Release Oral TabletSYe8c8dd18-9d95-4068-9762-bec1eb1bc25c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52544-695-10525440695101000 in 1 BOTTLE, PLASTICHistorical
52544-695-195254406951990 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-695-19) 2011-03-280000-00-00NoNoCurrent
52544-695-305254406953030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-695-30) 2011-03-280000-00-00NoNoCurrent