FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
71335-0643
11-digit product format
713350643
Labeler code
71335
Product ID
71335-0643_7e6a9719-c345-4c8c-96ed-5f21905e536a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075116
Marketing category
ANDA
Marketing start
1999-12-28
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
180 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 HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830845

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
71335-0643-1Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
71335-0643-2Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0643-1EA - Each71335-0643760cc521-11fe-40b1-88e1-0fa78b7006f512018-09-05
71335-0643-2EA - Each71335-064324a86115-5cf4-48ae-95de-b7e04938ba7812018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0643DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 2 package rows20200122_609e97e5-ebc7-4268-84ea-f279284c89e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN609e97e5-ebc7-4268-84ea-f279284c89e23
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD609e97e5-ebc7-4268-84ea-f279284c89e23
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY609e97e5-ebc7-4268-84ea-f279284c89e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0643-17133506430130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0643-1) 2018-01-050000-00-00NoNoCurrent
71335-0643-27133506430290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0643-2) 2018-01-050000-00-00NoNoCurrent