FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
60687-195
11-digit product format
606870195
Labeler code
60687
Product ID
60687-195_18597a1d-035b-fba0-e063-6294a90abecf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA074984
Marketing category
ANDA
Marketing start
2016-11-16
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 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 HYDROCHLORIDE120 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-195-01Diltiazem HydrochlorideExtended-Release100 in 1 BOX, UNIT-DOSECAPSULE, COATED, EXTENDED RELEAS1009
60687-195-11Diltiazem HydrochlorideExtended-Release1 in 1 BLISTER PACKCAPSULE, COATED, EXTENDED RELEAS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-195-01EA - Each60687-195b777bbda-13e3-472b-b531-38daaa83d51212017-03-06
60687-195-11EA - Each60687-1952c13983c-ae2e-49ba-991a-b7fc83b9d46b12017-03-06
60687-195-30EA - Each60687-195235304c6-8aaf-46fd-983f-a5b86fc14d9812017-06-15
60687-195-90EA - Each60687-1953b980bf4-d082-49e2-bf9e-a18701c9786112017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-195DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 2 package rows20240514_11b43a17-8038-462b-8902-259431ad5256.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN11b43a17-8038-462b-8902-259431ad52569
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN11b43a17-8038-462b-8902-259431ad52569
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 CapsuleSCD11b43a17-8038-462b-8902-259431ad52569
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD11b43a17-8038-462b-8902-259431ad52569
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 CapsuleSY11b43a17-8038-462b-8902-259431ad52569
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY11b43a17-8038-462b-8902-259431ad52569
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-195-0160687019501100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-195-01) / 1 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK (60687-195-11) 100 blister pack2016-11-160000-00-00NoNoCurrent
60687-195-11606870195111 in 1 BLISTER PACKHistorical