FDA.reportPublic FDA data

DILTIAZEM HYDROCHLORIDE

Product NDC
16714-523
11-digit product format
167140523
Labeler code
16714
Product ID
16714-523_174fcbb5-73f2-9d6d-8d3b-74f7ed2615f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DILTIAZEM HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NORTHSTAR RX LLC
Application
ANDA074943
Marketing category
ANDA
Marketing start
2022-02-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DILTIAZEM HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE120 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
16714-523-01DILTIAZEM HYDROCHLORIDE100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1004
16714-523-02DILTIAZEM HYDROCHLORIDE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-523DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTHSTAR RX LLC]3Current NDC, Legacy NDC, 2 package rows20240926_56616fc9-f3f7-8e0a-22c8-a6af106e6b1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-523-0116714052301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-523-01) 2022-02-220000-00-00NoNoCurrent
16714-523-0216714052302500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-523-02) 2022-02-220000-00-00NoNoCurrent