TEMAZEPAM

Product NDC
61919-438
11-digit product format
619190438
Labeler code
61919
Product ID
61919-438_f2140c0c-7b2e-2096-e053-2995a90ad56e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TEMAZEPAM
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
ANDA071620
Marketing category
ANDA
Marketing start
2014-01-01
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
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-438-302025-01-30C16284748780-12cef2736-a024-d83d-e063-dadaa90ab31fTEMAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-438-30TEMAZEPAM30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-438-30EA - Each61919-4380d84e27d-6c8c-40e1-8373-6c6c01a0837712014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [DIRECT RX]1
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTEMAZEPAM CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TEMAZEPAM CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-438TEMAZEPAM CAPSULE [DIRECT RX]5Legacy NDC, 1 package rows20230422_5de3751c-66d8-4b77-8698-12b67aa5f9e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198242temazepam 30 MG Oral CapsulePSN5de3751c-66d8-4b77-8698-12b67aa5f9e85
198242temazepam 30 MG Oral CapsuleSCD5de3751c-66d8-4b77-8698-12b67aa5f9e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-438-306191904383030 CAPSULE in 1 BOTTLE (61919-438-30) 30 capsule2015-01-010000-00-00NoNoCurrent