FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
21695-404
11-digit product format
216950404
Labeler code
21695
Product ID
21695-404_a5391476-8480-401d-8bb5-0726d8195770
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074984
Marketing category
ANDA
Marketing start
1999-12-20
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-404-302019-09-24C16284748780-1934fe258-4ba8-48b1-e053-8cdaa90a720aDILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-404-30Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-404-30EA - Each21695-4045b0a9bf7-fd9e-4048-a4d8-583475153d3512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diltiazem HydrochlorideACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
DiltiazemACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
AMMONIO METHACRYLATE COPOLYMER TYPE AINACTIVE INGREDIENT8GQS4E66YYDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
AMMONIO METHACRYLATE COPOLYMER TYPE BINACTIVE INGREDIENT161H3B14U2DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71ODILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-404DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110103_a5391476-8480-401d-8bb5-0726d8195770.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNa5391476-8480-401d-8bb5-0726d81957701
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNa5391476-8480-401d-8bb5-0726d81957701
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNa5391476-8480-401d-8bb5-0726d81957701
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDa5391476-8480-401d-8bb5-0726d81957701
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDa5391476-8480-401d-8bb5-0726d81957701
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDa5391476-8480-401d-8bb5-0726d81957701
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYa5391476-8480-401d-8bb5-0726d81957701
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYa5391476-8480-401d-8bb5-0726d81957701
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYa5391476-8480-401d-8bb5-0726d81957701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-404-302169504043030 in 1 BOTTLEHistorical