FDA.reportPublic FDA data

Temazepam

Product NDC
67544-038
11-digit product format
675440038
Labeler code
67544
Product ID
67544-038_100df325-8fc5-4e54-95d9-19c8b1f81a13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071427
Marketing category
ANDA
Marketing start
1988-01-12
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
15 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
67544-038-102020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-038-142020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-038-152020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-038-202020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-038-282020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-038-302020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-038-452020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-038-532020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV
67544-038-602020-01-31C16284748780-19d75b9d0-5c68-f424-e053-dadaa90a57ceTemazepam Capsules, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-038-10Temazepam10 in 1 BOTTLE, PLASTICCAPSULE102
67544-038-14Temazepam14 in 1 BOTTLE, PLASTICCAPSULE142
67544-038-15Temazepam15 in 1 BOTTLE, PLASTICCAPSULE152
67544-038-20Temazepam20 in 1 BOTTLE, PLASTICCAPSULE202
67544-038-28Temazepam28 in 1 BOTTLE, PLASTICCAPSULE282
67544-038-30Temazepam30 in 1 BOTTLE, PLASTICCAPSULE302
67544-038-45Temazepam45 in 1 BOTTLE, PLASTICCAPSULE452
67544-038-53Temazepam60 in 1 BOTTLE, PLASTICCAPSULE602
67544-038-60Temazepam90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-038-10EA - Each67544-0383d22ffe9-e343-44d4-829e-345e97c4553212013-06-04
67544-038-14EA - Each67544-03862cdd222-ca2a-4c48-8a32-b1076be55a5e12013-06-04
67544-038-15EA - Each67544-0384eef817c-712c-4d5e-873b-bf985921365112013-02-13
67544-038-20EA - Each67544-0385a019140-6ce2-48ea-b949-c999845efc5b12013-02-13
67544-038-28EA - Each67544-038542b0890-c5f1-4ba0-b33d-b1f8d65030a812013-07-02
67544-038-30EA - Each67544-038ded74dac-f91e-4c2b-bfba-07aba174602612013-02-13
67544-038-45EA - Each67544-038b0240007-360c-421c-9ce9-b955ac8c57cb12013-06-04
67544-038-53EA - Each67544-038ff0a2614-96c1-4383-a1a6-d2b97b69ccbb12013-02-13
67544-038-60EA - Each67544-038826e4f8a-5c97-4f66-859d-7aaba5b36e6d12013-02-13

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
67544-038TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 9 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
67544-038-106754400381010 in 1 BOTTLE, PLASTICHistorical
67544-038-146754400381414 in 1 BOTTLE, PLASTICHistorical
67544-038-156754400381515 in 1 BOTTLE, PLASTICHistorical
67544-038-206754400382020 in 1 BOTTLE, PLASTICHistorical
67544-038-286754400382828 in 1 BOTTLE, PLASTICHistorical
67544-038-306754400383030 in 1 BOTTLE, PLASTICHistorical
67544-038-456754400384545 in 1 BOTTLE, PLASTICHistorical
67544-038-536754400385360 in 1 BOTTLE, PLASTICHistorical
67544-038-606754400386090 in 1 BOTTLE, PLASTICHistorical