FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
63187-769
11-digit product format
631870769
Labeler code
63187
Product ID
63187-769_8cfc7ee8-ec1c-478b-bd90-6778f9c3fb98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074185
Marketing category
ANDA
Marketing start
1995-12-26
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
Rxcui831054

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
63187-769-10Diltiazem Hydrochloride10 in 1 BOTTLETABLET, FILM COATED105
63187-769-30Diltiazem Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
63187-769-60Diltiazem Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
63187-769-90Diltiazem Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-769-30EA - Each63187-769ac4c1e45-bfdf-4dab-9b10-2f0c3a80c6c412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-769DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20230528_a24255a3-88b1-47ef-90fc-51619a1c5a63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831054dilTIAZem hydrochloride 120 MG Oral TabletPSNa24255a3-88b1-47ef-90fc-51619a1c5a635
831054diltiazem hydrochloride 120 MG Oral TabletSCDa24255a3-88b1-47ef-90fc-51619a1c5a635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-769-106318707691010 TABLET, FILM COATED in 1 BOTTLE (63187-769-10) 2016-11-010000-00-00NoNoCurrent
63187-769-306318707693030 TABLET, FILM COATED in 1 BOTTLE (63187-769-30) 2016-11-010000-00-00NoNoCurrent
63187-769-606318707696060 TABLET, FILM COATED in 1 BOTTLE (63187-769-60) 2016-11-010000-00-00NoNoCurrent
63187-769-906318707699090 TABLET, FILM COATED in 1 BOTTLE (63187-769-90) 2023-05-24NoNoCurrent