FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
47335-669
11-digit product format
473350669
Labeler code
47335
Product ID
47335-669_ecddf1f1-b8e7-4a08-8f00-6cc484092a5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090421
Marketing category
ANDA
Marketing start
2010-11-15
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
Rxcui830795, 830801, 830837, 830845, 830861

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
47335-669-13Diltiazem Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50011
47335-669-18Diltiazem Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100011
47335-669-19Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9011
47335-669-81Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9011
47335-669-83Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-669-13EA - Each47335-66907c5b6f6-0595-4a5a-8ae4-1956ec91c48c12012-07-24
47335-669-81EA - Each47335-6697b6c6b01-1133-4ecc-aafc-f0f36cd064d712012-07-24
47335-669-83EA - Each47335-66968b11db3-cea0-478f-bdf1-66f25d3511be12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
GELATININACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
TALCINACTIVE INGREDIENT7SEV7J4R1UDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-669DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 5 package rows20230812_eebf29fe-ce22-4482-b850-5854550bf2c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNeebf29fe-ce22-4482-b850-5854550bf2c411
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNeebf29fe-ce22-4482-b850-5854550bf2c411
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNeebf29fe-ce22-4482-b850-5854550bf2c411
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNeebf29fe-ce22-4482-b850-5854550bf2c411
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSNeebf29fe-ce22-4482-b850-5854550bf2c411
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDeebf29fe-ce22-4482-b850-5854550bf2c411
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDeebf29fe-ce22-4482-b850-5854550bf2c411
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDeebf29fe-ce22-4482-b850-5854550bf2c411
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDeebf29fe-ce22-4482-b850-5854550bf2c411
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCDeebf29fe-ce22-4482-b850-5854550bf2c411
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYeebf29fe-ce22-4482-b850-5854550bf2c411
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYeebf29fe-ce22-4482-b850-5854550bf2c411
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYeebf29fe-ce22-4482-b850-5854550bf2c411
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYeebf29fe-ce22-4482-b850-5854550bf2c411
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSYeebf29fe-ce22-4482-b850-5854550bf2c411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-669-1347335066913500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-13) 2010-11-150000-00-00NoNoCurrent
47335-669-18473350669181000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-18) 2010-11-150000-00-00NoNoCurrent
47335-669-194733506691990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-19) 2010-11-150000-00-00NoNoCurrent
47335-669-814733506698190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-81) 2010-11-150000-00-00NoNoCurrent
47335-669-834733506698330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-83) 2010-11-150000-00-00NoNoCurrent