FDA.reportPublic FDA data

DILTIAZEM HYDROCHLORIDE

Product NDC
69097-995
11-digit product format
690970995
Labeler code
69097
Product ID
69097-995_8e10fac2-bb4b-4d93-ad8c-4fd93278a91e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cipla USA, Inc.
Application
ANDA216327
Marketing category
ANDA
Marketing start
2023-06-12
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 HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE300 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
69097-995-02DILTIAZEM HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
69097-995-05DILTIAZEM HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-995-02EA - Each69097-99576ac6e69-c23a-456b-a24a-4b7522ba5ebf12023-08-08
69097-995-05EA - Each69097-9956f7e7d33-483c-4cbc-b682-7d63ba8e51d712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-995DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE [CIPLA USA, INC.]1Current NDC, 2 package rows20230623_bce61158-201d-458c-be0c-9bdd2d3a0bec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830874dilTIAZem hydrochloride 120 MG 24HR Extended Release Oral TabletPSNbce61158-201d-458c-be0c-9bdd2d3a0bec2
830877dilTIAZem hydrochloride 180 MG 24HR Extended Release Oral TabletPSNbce61158-201d-458c-be0c-9bdd2d3a0bec2
830879dilTIAZem hydrochloride 240 MG 24HR Extended Release Oral TabletPSNbce61158-201d-458c-be0c-9bdd2d3a0bec2
830882dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral TabletPSNbce61158-201d-458c-be0c-9bdd2d3a0bec2
830897dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral TabletPSNbce61158-201d-458c-be0c-9bdd2d3a0bec2
830900dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral TabletPSNbce61158-201d-458c-be0c-9bdd2d3a0bec2
83087424 HR diltiazem hydrochloride 120 MG Extended Release Oral TabletSCDbce61158-201d-458c-be0c-9bdd2d3a0bec2
83087724 HR diltiazem hydrochloride 180 MG Extended Release Oral TabletSCDbce61158-201d-458c-be0c-9bdd2d3a0bec2
83087924 HR diltiazem hydrochloride 240 MG Extended Release Oral TabletSCDbce61158-201d-458c-be0c-9bdd2d3a0bec2
83088224 HR diltiazem hydrochloride 300 MG Extended Release Oral TabletSCDbce61158-201d-458c-be0c-9bdd2d3a0bec2
83089724 HR diltiazem hydrochloride 360 MG Extended Release Oral TabletSCDbce61158-201d-458c-be0c-9bdd2d3a0bec2
83090024 HR diltiazem hydrochloride 420 MG Extended Release Oral TabletSCDbce61158-201d-458c-be0c-9bdd2d3a0bec2
830874diltiazem hydrochloride 120 MG 24 HR Extended Release Oral TabletSYbce61158-201d-458c-be0c-9bdd2d3a0bec2
830877diltiazem hydrochloride 180 MG 24 HR Extended Release Oral TabletSYbce61158-201d-458c-be0c-9bdd2d3a0bec2
830879diltiazem hydrochloride 240 MG 24 HR Extended Release Oral TabletSYbce61158-201d-458c-be0c-9bdd2d3a0bec2
830882diltiazem hydrochloride 300 MG 24 HR Extended Release Oral TabletSYbce61158-201d-458c-be0c-9bdd2d3a0bec2
830897diltiazem hydrochloride 360 MG 24 HR Extended Release Oral TabletSYbce61158-201d-458c-be0c-9bdd2d3a0bec2
830900diltiazem hydrochloride 420 MG 24 HR Extended Release Oral TabletSYbce61158-201d-458c-be0c-9bdd2d3a0bec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69097-995-026909709950230 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-995-02) 2023-06-12NoNoHistorical
69097-995-056909709950590 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-995-05) 2023-06-12NoNoHistorical