FDA.reportPublic FDA data

Temazepam

Product NDC
67544-373
11-digit product format
675440373
Labeler code
67544
Product ID
67544-373_100df325-8fc5-4e54-95d9-19c8b1f81a13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071428
Marketing category
ANDA
Marketing start
1988-01-12
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
30 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67544-373-102020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-373-152020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-373-202020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-373-282020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-373-302020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-373-532020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-373-592020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-373-602020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-373-10Temazepam10 in 1 BOTTLE, PLASTICCAPSULE102
67544-373-15Temazepam15 in 1 BOTTLE, PLASTICCAPSULE152
67544-373-20Temazepam20 in 1 BOTTLE, PLASTICCAPSULE202
67544-373-28Temazepam28 in 1 BOTTLE, PLASTICCAPSULE282
67544-373-30Temazepam30 in 1 BOTTLE, PLASTICCAPSULE302
67544-373-53Temazepam60 in 1 BOTTLE, PLASTICCAPSULE602
67544-373-59Temazepam22 in 1 BOTTLE, PLASTICCAPSULE222
67544-373-60Temazepam90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-373-10EA - Each67544-373056a754f-1eb7-4709-8389-ba7063043cca12013-07-02
67544-373-15EA - Each67544-373077435c2-17df-444d-8cb5-afdaec22c4f412013-06-04
67544-373-20EA - Each67544-37309066940-dd2f-4bfb-8c05-459d0a930cd512014-07-02
67544-373-28EA - Each67544-373f845bb07-700f-491f-8591-df646293578112013-07-02
67544-373-30EA - Each67544-37363effed2-2ba4-4a66-a53f-1d85800318f712013-06-04
67544-373-53EA - Each67544-373ebd19c70-97ec-4721-92d2-63b238c3a2e412014-09-03
67544-373-59EA - Each67544-3738cf6fb0f-08d2-4c25-a0cd-39ec8b273ed412013-07-02
67544-373-60EA - Each67544-3739e83a209-e68b-4f7f-aa8a-26164daf6c7712014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SHELLACINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-373TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 8 package rows20130513_a2a65116-b351-4833-8813-c975161dad6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSNa2a65116-b351-4833-8813-c975161dad6a2
198242temazepam 30 MG Oral CapsulePSNa2a65116-b351-4833-8813-c975161dad6a2
198241temazepam 15 MG Oral CapsuleSCDa2a65116-b351-4833-8813-c975161dad6a2
198242temazepam 30 MG Oral CapsuleSCDa2a65116-b351-4833-8813-c975161dad6a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-373-106754403731010 in 1 BOTTLE, PLASTICHistorical
67544-373-156754403731515 in 1 BOTTLE, PLASTICHistorical
67544-373-206754403732020 in 1 BOTTLE, PLASTICHistorical
67544-373-286754403732828 in 1 BOTTLE, PLASTICHistorical
67544-373-306754403733030 in 1 BOTTLE, PLASTICHistorical
67544-373-536754403735360 in 1 BOTTLE, PLASTICHistorical
67544-373-596754403735922 in 1 BOTTLE, PLASTICHistorical
67544-373-606754403736090 in 1 BOTTLE, PLASTICHistorical