FDA.reportPublic FDA data

Flurazepam Hydrochloride

Product NDC
62135-737
11-digit product format
621350737
Labeler code
62135
Product ID
62135-737_25893c92-c8f1-567a-e063-6294a90a00d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurazepam Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA072369
Marketing category
ANDA
Marketing start
1989-03-30
Substance
FLURAZEPAM HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flurazepam Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLURAZEPAM HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii756RDM536M
Rxcui1298088, 1298091

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-737-30Flurazepam Hydrochloride30 in 1 BOTTLECAPSULE303
62135-737-90Flurazepam Hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-737-30EA - Each62135-73748115f69-9107-419b-a236-0af95fe7c47f12024-01-04
62135-737-90EA - Each62135-737bac88da2-43c4-4d2e-8ca8-4bca1df9962312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-737FLURAZEPAM HYDROCHLORIDE CAPSULE [CHARTWELL RX, LLC]3Current NDC, 2 package rows20241030_8f476891-1346-4e8c-ac1b-f8cbdc64f5a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298088flurazepam HCl 15 MG Oral CapsulePSN8f476891-1346-4e8c-ac1b-f8cbdc64f5a13
1298091flurazepam HCl 30 MG Oral CapsulePSN8f476891-1346-4e8c-ac1b-f8cbdc64f5a13
1298088flurazepam hydrochloride 15 MG Oral CapsuleSCD8f476891-1346-4e8c-ac1b-f8cbdc64f5a13
1298091flurazepam hydrochloride 30 MG Oral CapsuleSCD8f476891-1346-4e8c-ac1b-f8cbdc64f5a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-737-306213507373030 CAPSULE in 1 BOTTLE (62135-737-30) 30 capsule2023-12-19NoNoHistorical
62135-737-906213507379090 CAPSULE in 1 BOTTLE (62135-737-90) 90 capsule2023-09-08NoNoHistorical