temazepam

Product NDC
66267-321
11-digit product format
662670321
Labeler code
66267
Product ID
66267-321_1fa6afe6-d923-02d3-e063-6394a90a41c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA071457
Marketing category
ANDA
Marketing start
1987-04-21
Substance
TEMAZEPAM
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
temazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMAZEPAM30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCHB1QD2QSS
Rxcui198242

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
66267-321-302020-03-06C16284748780-19d75b9cf-faeb-f424-e053-dadaa90a57ce62fc08cd-8143-1652-e053-2a91aa0ad7ed
66267-321-302020-01-31C16284748780-19d75b9cf-faeb-f424-e053-dadaa90a57ce62fc08cd-8143-1652-e053-2a91aa0ad7ed

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-321-30temazepam30 in 1 BOTTLECAPSULE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-321TEMAZEPAM CAPSULE [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 1 package rows20240815_62fc08cd-8143-1652-e053-2a91aa0ad7ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198242temazepam 30 MG Oral CapsulePSN62fc08cd-8143-1652-e053-2a91aa0ad7ed6
198242temazepam 30 MG Oral CapsuleSCD62fc08cd-8143-1652-e053-2a91aa0ad7ed6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-321-306626703213030 CAPSULE in 1 BOTTLE (66267-321-30) 30 capsule2018-01-170000-00-00NoNoCurrent