FDA.reportPublic FDA data

Flurazepam

Product NDC
52959-236
11-digit product format
529590236
Labeler code
52959
Product ID
52959-236_534aaa8b-7a83-4a14-9c08-c1972632fc26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurazepam Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA071108
Marketing category
ANDA
Marketing start
1986-12-08
Marketing end
0000-00-00
Substance
FLURAZEPAM HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
af12b19d-88f8-90fa-798d-f1e0ce812052Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-236-142020-01-31C16284748780-19d75b9cf-d78a-f424-e053-dadaa90a57ceFlurazepam Hydrochloride Capsules, USP
52959-236-152020-01-31C16284748780-19d75b9cf-d78a-f424-e053-dadaa90a57ceFlurazepam Hydrochloride Capsules, USP
52959-236-202020-01-31C16284748780-19d75b9cf-d78a-f424-e053-dadaa90a57ceFlurazepam Hydrochloride Capsules, USP
52959-236-242020-01-31C16284748780-19d75b9cf-d78a-f424-e053-dadaa90a57ceFlurazepam Hydrochloride Capsules, USP
52959-236-302020-01-31C16284748780-19d75b9cf-d78a-f424-e053-dadaa90a57ceFlurazepam Hydrochloride Capsules, USP
52959-236-602020-01-31C16284748780-19d75b9cf-d78a-f424-e053-dadaa90a57ceFlurazepam Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-236-14Flurazepam14 in 1 BOTTLE, PLASTICCAPSULE142
52959-236-15Flurazepam15 in 1 BOTTLE, PLASTICCAPSULE152
52959-236-20Flurazepam20 in 1 BOTTLE, PLASTICCAPSULE202
52959-236-24Flurazepam24 in 1 BOTTLE, PLASTICCAPSULE242
52959-236-30Flurazepam30 in 1 BOTTLE, PLASTICCAPSULE302
52959-236-60Flurazepam60 in 1 BOTTLE, PLASTICCAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-236-14EA - Each52959-2366c358645-225e-414f-a9a7-4a5287e7bc1612012-07-24
52959-236-15EA - Each52959-2362995a961-9221-43e6-b03f-64a640e4a6a012012-07-24
52959-236-20EA - Each52959-2366bdf8601-fa03-44d4-ac70-24b93a92b66c12012-07-24
52959-236-30EA - Each52959-236caf8dded-9c10-4353-a2a0-6532d31842cc12012-07-24
52959-236-60EA - Each52959-236d7099064-5598-4157-80a5-7d7b6912aa6512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLURAZEPAM HYDROCHLORIDEACTIVE INGREDIENT756RDM536MFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
FLURAZEPAMACTIVE MOIETYIHP475989UFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-236FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 6 package rows20111207_50453bda-bf59-4f1e-bf36-bc3f039b2857.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298091flurazepam HCl 30 MG Oral CapsulePSN50453bda-bf59-4f1e-bf36-bc3f039b28572
1298091flurazepam hydrochloride 30 MG Oral CapsuleSCD50453bda-bf59-4f1e-bf36-bc3f039b28572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-236-145295902361414 in 1 BOTTLE, PLASTICHistorical
52959-236-155295902361515 in 1 BOTTLE, PLASTICHistorical
52959-236-205295902362020 in 1 BOTTLE, PLASTICHistorical
52959-236-245295902362424 in 1 BOTTLE, PLASTICHistorical
52959-236-305295902363030 in 1 BOTTLE, PLASTICHistorical
52959-236-605295902366060 in 1 BOTTLE, PLASTICHistorical