FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
70436-197
11-digit product format
704360197
Labeler code
70436
Product ID
70436-197_4dfe0355-d9cc-774d-e063-6294a90a85c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA216439
Marketing category
ANDA
Marketing start
2023-03-20
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
240 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 HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830874, 830877, 830879, 830882, 830897, 830900

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
70436-197-04Diltiazem Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE309
70436-197-06Diltiazem Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-197-04EA - Each70436-19783d60a8e-8a46-493e-9c2d-1551c4f6d5b312023-04-07
70436-197-06EA - Each70436-197137509c8-4f9f-415e-9376-3521ae54b53a12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-197DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]6Current NDC, 2 package rows20240620_f7137458-0db3-7ecd-e053-6394a90a5f95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830874dilTIAZem hydrochloride 120 MG 24HR Extended Release Oral TabletPSNf7137458-0db3-7ecd-e053-6394a90a5f959
830877dilTIAZem hydrochloride 180 MG 24HR Extended Release Oral TabletPSNf7137458-0db3-7ecd-e053-6394a90a5f959
830879dilTIAZem hydrochloride 240 MG 24HR Extended Release Oral TabletPSNf7137458-0db3-7ecd-e053-6394a90a5f959
830882dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral TabletPSNf7137458-0db3-7ecd-e053-6394a90a5f959
830897dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral TabletPSNf7137458-0db3-7ecd-e053-6394a90a5f959
830900dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral TabletPSNf7137458-0db3-7ecd-e053-6394a90a5f959
83087424 HR diltiazem hydrochloride 120 MG Extended Release Oral TabletSCDf7137458-0db3-7ecd-e053-6394a90a5f959
83087724 HR diltiazem hydrochloride 180 MG Extended Release Oral TabletSCDf7137458-0db3-7ecd-e053-6394a90a5f959
83087924 HR diltiazem hydrochloride 240 MG Extended Release Oral TabletSCDf7137458-0db3-7ecd-e053-6394a90a5f959
83088224 HR diltiazem hydrochloride 300 MG Extended Release Oral TabletSCDf7137458-0db3-7ecd-e053-6394a90a5f959
83089724 HR diltiazem hydrochloride 360 MG Extended Release Oral TabletSCDf7137458-0db3-7ecd-e053-6394a90a5f959
83090024 HR diltiazem hydrochloride 420 MG Extended Release Oral TabletSCDf7137458-0db3-7ecd-e053-6394a90a5f959
830874diltiazem hydrochloride 120 MG 24 HR Extended Release Oral TabletSYf7137458-0db3-7ecd-e053-6394a90a5f959
830877diltiazem hydrochloride 180 MG 24 HR Extended Release Oral TabletSYf7137458-0db3-7ecd-e053-6394a90a5f959
830879diltiazem hydrochloride 240 MG 24 HR Extended Release Oral TabletSYf7137458-0db3-7ecd-e053-6394a90a5f959
830882diltiazem hydrochloride 300 MG 24 HR Extended Release Oral TabletSYf7137458-0db3-7ecd-e053-6394a90a5f959
830897diltiazem hydrochloride 360 MG 24 HR Extended Release Oral TabletSYf7137458-0db3-7ecd-e053-6394a90a5f959
830900diltiazem hydrochloride 420 MG 24 HR Extended Release Oral TabletSYf7137458-0db3-7ecd-e053-6394a90a5f959

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70436-197-047043601970430 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-197-04) 2023-03-20NoNoCurrent
70436-197-067043601970690 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-197-06) 2023-03-20NoNoCurrent