FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
10370-831
11-digit product format
103700831
Labeler code
10370
Product ID
10370-831_0c13ca26-597e-4886-b085-85bc95eb3ceb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA074984
Marketing category
ANDA
Marketing start
2015-10-01
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
240 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
Diltiazem Hydrochloride
Brand name suffix
Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830801, 830837, 830845, 830861

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10370-831-052022-09-23C16284748780-1e4f33bdf-9e6c-d8a0-e053-dadaa90a6e4eDiltiazem Hydrochloride Extended-Release Capsules, USP Rx only
10370-831-092022-09-23C16284748780-1e4f33bdf-9e6c-d8a0-e053-dadaa90a6e4eDiltiazem Hydrochloride Extended-Release Capsules, USP Rx only
10370-831-112022-09-23C16284748780-1e4f33bdf-9e6c-d8a0-e053-dadaa90a6e4eDiltiazem Hydrochloride Extended-Release Capsules, USP Rx only
10370-831-052022-07-29C16284748780-1e4f33bdf-9e6c-d8a0-e053-dadaa90a6e4eDiltiazem Hydrochloride Extended-Release Capsules, USP Rx only
10370-831-092022-07-29C16284748780-1e4f33bdf-9e6c-d8a0-e053-dadaa90a6e4eDiltiazem Hydrochloride Extended-Release Capsules, USP Rx only
10370-831-112022-07-29C16284748780-1e4f33bdf-9e6c-d8a0-e053-dadaa90a6e4eDiltiazem Hydrochloride Extended-Release Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10370-831-05Diltiazem HydrochlorideExtended-Release500 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS50010
10370-831-09Diltiazem HydrochlorideExtended-Release90 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS9010
10370-831-11Diltiazem HydrochlorideExtended-Release30 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10370-831DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [ENDO USA, INC.]10Current NDC, Legacy NDC, 3 package rows20241212_a66ad880-cdab-435a-a6f2-574cfdfd1ac3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNde2a0c48-7fc4-4760-b465-a79299876e6e102
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6102
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDde2a0c48-7fc4-4760-b465-a79299876e6e102
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6102
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYde2a0c48-7fc4-4760-b465-a79299876e6e102
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6102
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNfe88ae79-095c-46db-966f-45cbcfaf6f0134
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNfe88ae79-095c-46db-966f-45cbcfaf6f0134
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNfe88ae79-095c-46db-966f-45cbcfaf6f0134
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNfe88ae79-095c-46db-966f-45cbcfaf6f0134
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDfe88ae79-095c-46db-966f-45cbcfaf6f0134
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDfe88ae79-095c-46db-966f-45cbcfaf6f0134
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDfe88ae79-095c-46db-966f-45cbcfaf6f0134
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDfe88ae79-095c-46db-966f-45cbcfaf6f0134
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYfe88ae79-095c-46db-966f-45cbcfaf6f0134
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYfe88ae79-095c-46db-966f-45cbcfaf6f0134
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYfe88ae79-095c-46db-966f-45cbcfaf6f0134
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYfe88ae79-095c-46db-966f-45cbcfaf6f0134
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNa66ad880-cdab-435a-a6f2-574cfdfd1ac310
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNa66ad880-cdab-435a-a6f2-574cfdfd1ac310
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNa66ad880-cdab-435a-a6f2-574cfdfd1ac310
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNa66ad880-cdab-435a-a6f2-574cfdfd1ac310
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDa66ad880-cdab-435a-a6f2-574cfdfd1ac310
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDa66ad880-cdab-435a-a6f2-574cfdfd1ac310
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDa66ad880-cdab-435a-a6f2-574cfdfd1ac310
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDa66ad880-cdab-435a-a6f2-574cfdfd1ac310
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYa66ad880-cdab-435a-a6f2-574cfdfd1ac310
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYa66ad880-cdab-435a-a6f2-574cfdfd1ac310
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYa66ad880-cdab-435a-a6f2-574cfdfd1ac310
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYa66ad880-cdab-435a-a6f2-574cfdfd1ac310
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN11b43a17-8038-462b-8902-259431ad52569
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN11b43a17-8038-462b-8902-259431ad52569
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN11b43a17-8038-462b-8902-259431ad52569
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN11b43a17-8038-462b-8902-259431ad52569
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD11b43a17-8038-462b-8902-259431ad52569
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD11b43a17-8038-462b-8902-259431ad52569
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD11b43a17-8038-462b-8902-259431ad52569
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD11b43a17-8038-462b-8902-259431ad52569
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY11b43a17-8038-462b-8902-259431ad52569
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY11b43a17-8038-462b-8902-259431ad52569
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY11b43a17-8038-462b-8902-259431ad52569
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY11b43a17-8038-462b-8902-259431ad52569

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-831-0510370083105500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-831-05) 2017-01-120000-00-00NoNoCurrent
10370-831-091037008310990 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-831-09) 2017-02-130000-00-00NoNoCurrent
10370-831-111037008311130 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-831-11) 2017-02-130000-00-00NoNoCurrent