Flurazepam

Product NDC
21695-363
11-digit product format
216950363
Labeler code
21695
Product ID
21695-363_16a5de2d-2f89-4fc2-a1cf-2d6fd11f2748
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurazepam Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
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
2017-12-31
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
21695-363-302019-09-24C16284748780-1934fe258-4a4f-48b1-e053-8cdaa90a720aFlurazepam Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-363-30Flurazepam30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-363-30EA - Each21695-363df40b19e-0d5b-470b-b3fe-6aa01cf2283212012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-363FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110103_16a5de2d-2f89-4fc2-a1cf-2d6fd11f2748.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298091flurazepam HCl 30 MG Oral CapsulePSN16a5de2d-2f89-4fc2-a1cf-2d6fd11f27481
1298091flurazepam hydrochloride 30 MG Oral CapsuleSCD16a5de2d-2f89-4fc2-a1cf-2d6fd11f27481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-363-302169503633030 in 1 BOTTLE, PLASTICHistorical