FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
0378-6202
11-digit product format
003786202
Labeler code
0378
Product ID
0378-6202_aeca5802-2f58-4302-827b-433c7b86cd7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA078306
Marketing category
ANDA
Marketing start
2007-08-09
Marketing end
2019-11-30
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea1f6fc8-bfc2-4421-a2eb-4e87c7c3e3c4Product name220230103
33ad674d-d105-6aa5-02fa-95ae4329b8cdProduct name220180809
3279bd6d-5b02-e60b-3857-c853a2deb2ddProduct name220170713
8ebb66e3-d7b3-f1e5-88aa-3369e64bb84aProduct name120140508
940a1faa-2df8-cc65-be37-1b97984b4ea3Product name120140508
d3b67bc2-0e96-e3ec-06a9-90afcc07bf13Product name120140508
e2fcd66c-a043-3187-790d-b0342deb1149Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6202-01EA - Each0378-6202be94a490-caee-40f8-9885-8cc90963835f12012-07-24
0378-6202-05EA - Each0378-62021fc076a8-f48a-444c-8e74-57caca7fd65212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897584verapamil HCl 100 MG 24HR Extended Release Oral CapsulePSNf77f9742-9100-4b64-ac73-dff94079b8882
897590verapamil HCl 200 MG 24HR Extended Release Oral CapsulePSNf77f9742-9100-4b64-ac73-dff94079b8882
897596verapamil HCl 300 MG 24HR Extended Release Oral CapsulePSNf77f9742-9100-4b64-ac73-dff94079b8882
89758424 HR verapamil hydrochloride 100 MG Extended Release Oral CapsuleSCDf77f9742-9100-4b64-ac73-dff94079b8882
89759024 HR verapamil hydrochloride 200 MG Extended Release Oral CapsuleSCDf77f9742-9100-4b64-ac73-dff94079b8882
89759624 HR verapamil hydrochloride 300 MG Extended Release Oral CapsuleSCDf77f9742-9100-4b64-ac73-dff94079b8882
897584verapamil hydrochloride 100 MG 24 HR Extended Release Oral CapsuleSYf77f9742-9100-4b64-ac73-dff94079b8882
897590verapamil hydrochloride 200 MG 24 HR Extended Release Oral CapsuleSYf77f9742-9100-4b64-ac73-dff94079b8882
897596verapamil hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYf77f9742-9100-4b64-ac73-dff94079b8882