Diltiazem HCl CD

Product NDC
68682-521
11-digit product format
686820521
Labeler code
68682
Product ID
68682-521_d6cc69c3-44a9-43e4-9b6a-2851c2e16b15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
NDA020062
Marketing category
NDA
Marketing start
2001-04-11
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
360 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-521-01EA - Each68682-521b24c1fbb-d565-456c-8c51-c5838126dc8a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diltiazem HydrochlorideACTIVE INGREDIENTOLH94387TEDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
DiltiazemACTIVE MOIETYEE92BBP03HDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
acetyltributyl citrateINACTIVE INGREDIENT0ZBX0N59RZDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
AMMONIO METHACRYLATE COPOLYMER TYPE AINACTIVE INGREDIENT8GQS4E66YYDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
AMMONIO METHACRYLATE COPOLYMER TYPE BINACTIVE INGREDIENT161H3B14U2DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
diethyl phthalateINACTIVE INGREDIENTUF064M00AFDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
gelatinINACTIVE INGREDIENT2G86QN327LDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
starch, cornINACTIVE INGREDIENTO8232NY3SJDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
sucroseINACTIVE INGREDIENTC151H8M554DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
talcINACTIVE INGREDIENT7SEV7J4R1UDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-521DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]10Legacy NDC20200625_5e39be50-ea17-4077-a2dc-668267049f6a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-521-016868205210190 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68682-521-01) 2016-06-300000-00-00NoNoCurrent