FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
0378-6060
11-digit product format
003786060
Labeler code
0378
Product ID
0378-6060_17bfacaf-75db-4179-9a06-244e94a28554
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074910
Marketing category
ANDA
Marketing start
1997-05-02
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diltiazem Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830865, 830869, 830872

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
0378-6060-01Diltiazem Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6060-01EA - Each0378-6060a5caf5a7-4587-4797-903c-4cf45271db2f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
GELATININACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]4
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6060DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20250130_ec7e93b8-666c-4d2f-8d08-07931e09f748.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830872dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral CapsulePSNec7e93b8-666c-4d2f-8d08-07931e09f74813
830865dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral CapsulePSNec7e93b8-666c-4d2f-8d08-07931e09f74813
830869dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral CapsulePSNec7e93b8-666c-4d2f-8d08-07931e09f74813
83087212 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDec7e93b8-666c-4d2f-8d08-07931e09f74813
83086512 HR diltiazem hydrochloride 60 MG Extended Release Oral CapsuleSCDec7e93b8-666c-4d2f-8d08-07931e09f74813
83086912 HR diltiazem hydrochloride 90 MG Extended Release Oral CapsuleSCDec7e93b8-666c-4d2f-8d08-07931e09f74813
830872diltiazem hydrochloride 120 MG 12 HR Extended Release Oral CapsuleSYec7e93b8-666c-4d2f-8d08-07931e09f74813
830865diltiazem hydrochloride 60 MG 12 HR Extended Release Oral CapsuleSYec7e93b8-666c-4d2f-8d08-07931e09f74813
830869diltiazem hydrochloride 90 MG 12 HR Extended Release Oral CapsuleSYec7e93b8-666c-4d2f-8d08-07931e09f74813
830872dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral CapsulePSN9942f1a2-f66d-4d9e-9794-49bee8abf5ab10
830865dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral CapsulePSN9942f1a2-f66d-4d9e-9794-49bee8abf5ab10
830869dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral CapsulePSN9942f1a2-f66d-4d9e-9794-49bee8abf5ab10
83087212 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD9942f1a2-f66d-4d9e-9794-49bee8abf5ab10
83086512 HR diltiazem hydrochloride 60 MG Extended Release Oral CapsuleSCD9942f1a2-f66d-4d9e-9794-49bee8abf5ab10
83086912 HR diltiazem hydrochloride 90 MG Extended Release Oral CapsuleSCD9942f1a2-f66d-4d9e-9794-49bee8abf5ab10
830872diltiazem hydrochloride 120 MG 12 HR Extended Release Oral CapsuleSY9942f1a2-f66d-4d9e-9794-49bee8abf5ab10
830865diltiazem hydrochloride 60 MG 12 HR Extended Release Oral CapsuleSY9942f1a2-f66d-4d9e-9794-49bee8abf5ab10
830869diltiazem hydrochloride 90 MG 12 HR Extended Release Oral CapsuleSY9942f1a2-f66d-4d9e-9794-49bee8abf5ab10
830872dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral CapsulePSNfc02db0f-5311-4b61-896e-bfe3408327352
830865dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral CapsulePSNfc02db0f-5311-4b61-896e-bfe3408327352
830869dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral CapsulePSNfc02db0f-5311-4b61-896e-bfe3408327352
83087212 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDfc02db0f-5311-4b61-896e-bfe3408327352
83086512 HR diltiazem hydrochloride 60 MG Extended Release Oral CapsuleSCDfc02db0f-5311-4b61-896e-bfe3408327352
83086912 HR diltiazem hydrochloride 90 MG Extended Release Oral CapsuleSCDfc02db0f-5311-4b61-896e-bfe3408327352
830872diltiazem hydrochloride 120 MG 12 HR Extended Release Oral CapsuleSYfc02db0f-5311-4b61-896e-bfe3408327352
830865diltiazem hydrochloride 60 MG 12 HR Extended Release Oral CapsuleSYfc02db0f-5311-4b61-896e-bfe3408327352
830869diltiazem hydrochloride 90 MG 12 HR Extended Release Oral CapsuleSYfc02db0f-5311-4b61-896e-bfe3408327352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-6060-0100378606001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6060-01) 1997-05-020000-00-00NoNoCurrent