FDA.reportPublic FDA data

Diltiazem hydrochloride

Product NDC
50090-6328
11-digit product format
500906328
Labeler code
50090
Product ID
50090-6328_d786e289-37d8-4cb3-9bf0-967fbd5ebc2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203023
Marketing category
ANDA
Marketing start
2018-10-31
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
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
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
50090-6328-0Diltiazem hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
50090-6328-1Diltiazem hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6328-0EA - Each50090-632858a67b42-7886-4dd6-b993-5fa9850a68b912023-02-06
50090-6328-1EA - Each50090-6328f0f9b029-8e89-4a47-94c8-5e672e5ad0e112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6328DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230118_5460158f-7782-45f4-89b1-f84e6ba178d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN5460158f-7782-45f4-89b1-f84e6ba178d81
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD5460158f-7782-45f4-89b1-f84e6ba178d81
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY5460158f-7782-45f4-89b1-f84e6ba178d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6328-05009063280030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-6328-0) 2023-01-13NoNoHistorical
50090-6328-15009063280190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-6328-1) 2023-01-13NoNoHistorical