FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
33342-522
11-digit product format
333420522
Labeler code
33342
Product ID
33342-522_850566b1-0c8e-42bc-85fa-c8ee710f34ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA218744
Marketing category
ANDA
Marketing start
2023-06-23
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
Rxcui830795, 830801, 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
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-522-02Diltiazem Hydrochloride6 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE61
33342-522-07Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
33342-522-10Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN850566b1-0c8e-42bc-85fa-c8ee710f34ba1
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD850566b1-0c8e-42bc-85fa-c8ee710f34ba1
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD850566b1-0c8e-42bc-85fa-c8ee710f34ba1
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD850566b1-0c8e-42bc-85fa-c8ee710f34ba1
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD850566b1-0c8e-42bc-85fa-c8ee710f34ba1
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY850566b1-0c8e-42bc-85fa-c8ee710f34ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-522-02333420522026 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (33342-522-02) 2023-06-23NoNoCurrent
33342-522-073334205220730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-522-07) 2023-06-23NoNoCurrent
33342-522-103334205221090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-522-10) 2023-06-23NoNoCurrent