Diltiazem HCL ER

Product NDC
72189-409
11-digit product format
721890409
Labeler code
72189
Product ID
72189-409_2c4ce2c4-2b19-de10-e063-6394a90ad371
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem HCL ER
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA208783
Marketing category
ANDA
Marketing start
2023-01-10
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
300 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 HCL ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830801

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
72189-409-90Diltiazem HCL ER90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-409-90EA - Each72189-409c0a9d653-e75c-4915-a8ae-e39bc3d91f1c12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-409DILTIAZEM HCL ER CAPSULE, EXTENDED RELEASE [DIRECT_RX]3Current NDC, Legacy NDC, 1 package rows20250123_f1ea85b2-ecd2-5867-e053-2a95a90a24dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNf1ea85b2-ecd2-5867-e053-2a95a90a24dc3
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDf1ea85b2-ecd2-5867-e053-2a95a90a24dc3
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYf1ea85b2-ecd2-5867-e053-2a95a90a24dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-409-907218904099090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-409-90) 2023-01-100000-00-00NoNoCurrent