FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
68462-850
11-digit product format
684620850
Labeler code
68462
Product ID
68462-850_42982c30-aae0-4fa3-983c-500bd75b028c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA212317
Marketing category
ANDA
Marketing start
2021-03-22
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
68462-850-01Diltiazem Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-850-01EA - Each68462-850c97dc59d-c106-413d-b801-671ada93049212021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-850DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]3Current NDC, Legacy NDC, 1 package rows20240104_fb1606ea-1cff-46fd-b8e5-8135da76436c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830872dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral CapsulePSNfb1606ea-1cff-46fd-b8e5-8135da76436c4
830865dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral CapsulePSNfb1606ea-1cff-46fd-b8e5-8135da76436c4
830869dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral CapsulePSNfb1606ea-1cff-46fd-b8e5-8135da76436c4
83087212 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDfb1606ea-1cff-46fd-b8e5-8135da76436c4
83086512 HR diltiazem hydrochloride 60 MG Extended Release Oral CapsuleSCDfb1606ea-1cff-46fd-b8e5-8135da76436c4
83086912 HR diltiazem hydrochloride 90 MG Extended Release Oral CapsuleSCDfb1606ea-1cff-46fd-b8e5-8135da76436c4
830872diltiazem hydrochloride 120 MG 12 HR Extended Release Oral CapsuleSYfb1606ea-1cff-46fd-b8e5-8135da76436c4
830865diltiazem hydrochloride 60 MG 12 HR Extended Release Oral CapsuleSYfb1606ea-1cff-46fd-b8e5-8135da76436c4
830869diltiazem hydrochloride 90 MG 12 HR Extended Release Oral CapsuleSYfb1606ea-1cff-46fd-b8e5-8135da76436c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-850-0168462085001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-850-01) 2021-03-220000-00-00NoNoCurrent