FDA.reportPublic FDA data

Flurazepam Hydrochloride

Product NDC
0378-4430
11-digit product format
003784430
Labeler code
0378
Product ID
0378-4430_66fa1d6a-ee0e-4145-b5fc-52a12f7d0c95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flurazepam hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA070345
Marketing category
ANDA
Marketing start
1985-11-27
Marketing end
2023-01-31
Substance
FLURAZEPAM HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
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
af12b19d-88f8-90fa-798d-f1e0ce812052Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4430-01EA - Each0378-4430d6d5901b-c8c1-4660-a4ae-e5bf486b433a12012-07-24
0378-4430-05EA - Each0378-4430f44411d3-09bd-4cad-9ebc-0c9842a26e7812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLURAZEPAM HYDROCHLORIDEACTIVE INGREDIENT756RDM536MFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FLURAZEPAMACTIVE MOIETYIHP475989UFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298088flurazepam HCl 15 MG Oral CapsulePSN347eb1a3-1957-4a4b-a0d5-1576adae3d132
1298091flurazepam HCl 30 MG Oral CapsulePSN347eb1a3-1957-4a4b-a0d5-1576adae3d132
1298088flurazepam hydrochloride 15 MG Oral CapsuleSCD347eb1a3-1957-4a4b-a0d5-1576adae3d132
1298091flurazepam hydrochloride 30 MG Oral CapsuleSCD347eb1a3-1957-4a4b-a0d5-1576adae3d132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-4430-0100378443001100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4430-01) 100 capsule1985-11-272023-01-31NoNoCurrent