FDA.reportPublic FDA data

temazepam

Product NDC
63629-1619
11-digit product format
636291619
Labeler code
63629
Product ID
63629-1619_ca9c9c3f-cf46-4b88-9b14-58bc48ed1d5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071456
Marketing category
ANDA
Marketing start
1987-04-21
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

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
63629-1619-1temazepam20 in 1 BOTTLECAPSULE20103
63629-1619-2temazepam30 in 1 BOTTLECAPSULE30103
63629-1619-3temazepam60 in 1 BOTTLECAPSULE60103
63629-1619-4temazepam90 in 1 BOTTLECAPSULE90103
63629-1619-5temazepam28 in 1 BOTTLECAPSULE28103
63629-1619-6temazepam120 in 1 BOTTLECAPSULE120103
63629-1619-7temazepam100 in 1 BOTTLECAPSULE100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1619-1EA - Each63629-1619c1e87c65-6baa-4a4e-935a-d31ec529646e12013-02-13
63629-1619-2EA - Each63629-161971fbfc61-629e-4e79-92f7-1fe5dc47ffbf12012-07-24
63629-1619-3EA - Each63629-16190d9591bd-80dd-4aba-8c1b-b184c55359f512012-07-24
63629-1619-4EA - Each63629-16197bde0f80-fbf5-49df-9d67-08d972a76c1b12012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1619TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 7 package rows20240515_ac08a51c-6c54-40da-9626-a4c82f337a3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSNac08a51c-6c54-40da-9626-a4c82f337a3a103
198241temazepam 15 MG Oral CapsuleSCDac08a51c-6c54-40da-9626-a4c82f337a3a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1619-16362916190120 CAPSULE in 1 BOTTLE (63629-1619-1) 20 capsule2010-06-110000-00-00NoNoCurrent
63629-1619-26362916190230 CAPSULE in 1 BOTTLE (63629-1619-2) 30 capsule2006-10-100000-00-00NoNoCurrent
63629-1619-36362916190360 CAPSULE in 1 BOTTLE (63629-1619-3) 60 capsule2006-07-280000-00-00NoNoCurrent
63629-1619-46362916190490 CAPSULE in 1 BOTTLE (63629-1619-4) 90 capsule2008-09-150000-00-00NoNoCurrent
63629-1619-56362916190528 CAPSULE in 1 BOTTLE (63629-1619-5) 28 capsule2010-04-290000-00-00NoNoCurrent
63629-1619-663629161906120 CAPSULE in 1 BOTTLE (63629-1619-6) 120 capsule2022-06-220000-00-00NoNoCurrent
63629-1619-763629161907100 CAPSULE in 1 BOTTLE (63629-1619-7) 100 capsule2022-06-220000-00-00NoNoCurrent