FDA.reportPublic FDA data

diltiazem hydrochloride

Product NDC
68788-7870
11-digit product format
687887870
Labeler code
68788
Product ID
68788-7870_63cf2250-c568-4b74-849c-c39d9159560a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208783
Marketing category
ANDA
Marketing start
2021-02-15
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
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 HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830861

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
68788-7870-1diltiazem hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1007
68788-7870-3diltiazem hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
68788-7870-6diltiazem hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE607
68788-7870-8diltiazem hydrochloride120 in 1 BOTTLECAPSULE, EXTENDED RELEASE1207
68788-7870-9diltiazem hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7870-1EA - Each68788-78705c2895d1-6681-4822-83ff-2a016a5f962112021-03-02
68788-7870-3EA - Each68788-78702f2f3378-a804-4f69-9198-1977020bde3612021-03-02
68788-7870-6EA - Each68788-7870f30aa1a5-553d-4c98-9e57-14d27ce32b6712021-03-02
68788-7870-8EA - Each68788-7870c1e42feb-4d05-44fa-8d5d-7fe4016d520812021-03-02
68788-7870-9EA - Each68788-7870f4c5ff90-ce59-49ce-a990-0370f3d2da8312021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7870DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 5 package rows20250330_3d594530-885f-45c7-b8a5-fd7e503ff83f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN3d594530-885f-45c7-b8a5-fd7e503ff83f7
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD3d594530-885f-45c7-b8a5-fd7e503ff83f7
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY3d594530-885f-45c7-b8a5-fd7e503ff83f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7870-168788787001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-1) 2021-02-150000-00-00NoNoCurrent
68788-7870-36878878700330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-3) 2021-02-150000-00-00NoNoCurrent
68788-7870-66878878700660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-6) 2021-02-150000-00-00NoNoCurrent
68788-7870-868788787008120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-8) 2021-02-150000-00-00NoNoCurrent
68788-7870-96878878700990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7870-9) 2021-02-150000-00-00NoNoCurrent