FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
62332-816
11-digit product format
623320816
Labeler code
62332
Product ID
62332-816_e01b87fe-c495-4a9f-8195-2b6728d738d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA218587
Marketing category
ANDA
Marketing start
2024-10-28
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
180 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 HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830837, 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
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-816-31Diltiazem Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1004
62332-816-71Diltiazem Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5004
62332-816-91Diltiazem Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-816-31EA - Each62332-81678c5141d-f1ac-4c60-9d3b-b6e98a86dd2512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-816DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS INC.]3Current NDC, 3 package rows20241030_04a85be5-f746-418e-8e37-292703f16934.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN04a85be5-f746-418e-8e37-292703f169344
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN04a85be5-f746-418e-8e37-292703f169344
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN04a85be5-f746-418e-8e37-292703f169344
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD04a85be5-f746-418e-8e37-292703f169344
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD04a85be5-f746-418e-8e37-292703f169344
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD04a85be5-f746-418e-8e37-292703f169344
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY04a85be5-f746-418e-8e37-292703f169344
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY04a85be5-f746-418e-8e37-292703f169344
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY04a85be5-f746-418e-8e37-292703f169344

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-816-3162332081631100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-31) 2024-10-28NoNoHistorical
62332-816-7162332081671500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-71) 2024-10-28NoNoHistorical
62332-816-91623320816911000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-91) 2024-10-28NoNoHistorical