FDA.reportPublic FDA data

Temazepam

Product NDC
67544-136
11-digit product format
675440136
Labeler code
67544
Product ID
67544-136_6d75ac66-4a65-487b-a938-7414907c2632
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071638
Marketing category
ANDA
Marketing start
1987-08-03
Substance
TEMAZEPAM
Active strength
15 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
Temazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMAZEPAM15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCHB1QD2QSS
Rxcui198241, 198242

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-136-10Temazepam10 in 1 BOTTLE, PLASTICCAPSULE102
67544-136-14Temazepam14 in 1 BOTTLE, PLASTICCAPSULE142
67544-136-15Temazepam15 in 1 BOTTLE, PLASTICCAPSULE152
67544-136-20Temazepam20 in 1 BOTTLE, PLASTICCAPSULE202
67544-136-28Temazepam28 in 1 BOTTLE, PLASTICCAPSULE282
67544-136-30Temazepam30 in 1 BOTTLE, PLASTICCAPSULE302
67544-136-45Temazepam45 in 1 BOTTLE, PLASTICCAPSULE452
67544-136-53Temazepam60 in 1 BOTTLE, PLASTICCAPSULE602
67544-136-60Temazepam90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-136-10EA - Each67544-136c7894285-322e-4e1a-8a85-b622f2d3a05312013-06-04
67544-136-14EA - Each67544-136287b38e0-e065-4eb7-b633-73eeae48872b12013-06-04
67544-136-15EA - Each67544-136ea17b418-b11f-4729-b4b8-84cd6166921f12013-06-04
67544-136-20EA - Each67544-136a0751d24-35c5-450d-8c40-e8df56687cca12013-06-04
67544-136-28EA - Each67544-13652d1d49d-be61-4aca-b005-f246844d578d12013-07-02
67544-136-30EA - Each67544-136d4fb63b8-9d25-4987-86ce-9121f8d2cbcc12013-06-04
67544-136-45EA - Each67544-1363237950a-e33e-48bd-a3fc-dc297c47605d12013-06-04
67544-136-53EA - Each67544-136f2d2d25f-f50d-4b69-af2c-44a11227681e12013-06-04
67544-136-60EA - Each67544-136f9b7303d-93b5-4ed1-a3ee-dc9e4076f3d412013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-136TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 9 package rows20190531_2461dfbd-5704-42f4-bde7-d1461811d898.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSN2461dfbd-5704-42f4-bde7-d1461811d8982
198242temazepam 30 MG Oral CapsulePSN2461dfbd-5704-42f4-bde7-d1461811d8982
198241temazepam 15 MG Oral CapsuleSCD2461dfbd-5704-42f4-bde7-d1461811d8982
198242temazepam 30 MG Oral CapsuleSCD2461dfbd-5704-42f4-bde7-d1461811d8982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-136-106754401361010 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-10) 10 capsule2004-08-260000-00-00NoNoCurrent
67544-136-146754401361414 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-14) 14 capsule2004-08-260000-00-00NoNoCurrent
67544-136-156754401361515 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-15) 15 capsule2004-09-160000-00-00NoNoCurrent
67544-136-206754401362020 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-20) 20 capsule2004-09-010000-00-00NoNoCurrent
67544-136-286754401362828 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-28) 28 capsule2009-08-300000-00-00NoNoCurrent
67544-136-306754401363030 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-30) 30 capsule2004-10-160000-00-00NoNoCurrent
67544-136-456754401364545 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-45) 45 capsule2004-09-010000-00-00NoNoCurrent
67544-136-536754401365360 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-53) 60 capsule2004-10-160000-00-00NoNoCurrent
67544-136-606754401366090 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-60) 90 capsule2004-12-080000-00-00NoNoCurrent