FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
16714-554
11-digit product format
167140554
Labeler code
16714
Product ID
16714-554_9835b0d9-56df-4ebd-b5ac-987f38b48741
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA212317
Marketing category
ANDA
Marketing start
2022-06-23
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
90 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 HYDROCHLORIDE90 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
16714-554-01Diltiazem Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-554-01EA - Each16714-554913d72dd-96f8-4f8c-93c2-4baaf15b50f112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-554DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTHSTAR RX LLC]2Current NDC, Legacy NDC, 1 package rows20240103_e2511ffe-5821-4f64-a469-f8ef9618b1b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830872dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral CapsulePSNe2511ffe-5821-4f64-a469-f8ef9618b1b53
830865dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral CapsulePSNe2511ffe-5821-4f64-a469-f8ef9618b1b53
830869dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral CapsulePSNe2511ffe-5821-4f64-a469-f8ef9618b1b53
83087212 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDe2511ffe-5821-4f64-a469-f8ef9618b1b53
83086512 HR diltiazem hydrochloride 60 MG Extended Release Oral CapsuleSCDe2511ffe-5821-4f64-a469-f8ef9618b1b53
83086912 HR diltiazem hydrochloride 90 MG Extended Release Oral CapsuleSCDe2511ffe-5821-4f64-a469-f8ef9618b1b53
830872diltiazem hydrochloride 120 MG 12 HR Extended Release Oral CapsuleSYe2511ffe-5821-4f64-a469-f8ef9618b1b53
830865diltiazem hydrochloride 60 MG 12 HR Extended Release Oral CapsuleSYe2511ffe-5821-4f64-a469-f8ef9618b1b53
830869diltiazem hydrochloride 90 MG 12 HR Extended Release Oral CapsuleSYe2511ffe-5821-4f64-a469-f8ef9618b1b53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-554-0116714055401100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-554-01) 2022-06-230000-00-00NoNoCurrent