FDA.reportPublic FDA data

Temazepam

Product NDC
71335-0315
11-digit product format
713350315
Labeler code
71335
Product ID
71335-0315_1523be5f-9ff1-4e7c-b8ba-2e4a2c94862e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071620
Marketing category
ANDA
Marketing start
1990-09-30
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0315-12024-05-17C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-22024-05-17C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-32024-05-17C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-42024-05-17C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-52024-05-17C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-62024-05-17C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-72024-05-17C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-12024-01-30C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-22024-01-30C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-32024-01-30C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-42024-01-30C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-52024-01-30C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-62024-01-30C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only
71335-0315-72024-01-30C16284748780-11030e365-5625-111a-e063-dadaa90a10e2Temazepam Capsules, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0315-1Temazepam20 in 1 BOTTLECAPSULE2013
71335-0315-2Temazepam30 in 1 BOTTLECAPSULE3013
71335-0315-3Temazepam60 in 1 BOTTLECAPSULE6013
71335-0315-4Temazepam90 in 1 BOTTLECAPSULE9013
71335-0315-5Temazepam28 in 1 BOTTLECAPSULE2813
71335-0315-6Temazepam120 in 1 BOTTLECAPSULE12013
71335-0315-7Temazepam100 in 1 BOTTLECAPSULE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0315-1EA - Each71335-031592cb3f26-e3e3-47e5-a749-3c7b6f8bc72512018-03-08
71335-0315-2EA - Each71335-0315a5c91d50-f890-48a1-94a1-ee4543b4696412018-03-08
71335-0315-3EA - Each71335-0315095a1c69-96b0-4e68-819a-0c2b5b8dc22f12018-03-08
71335-0315-4EA - Each71335-031517e2eb86-f9a4-4858-bbf3-42b0466c31ff12018-03-08
71335-0315-5EA - Each71335-0315bbb4fe2d-56c3-421b-8b33-d67ae558239312018-03-08
71335-0315-6EA - Each71335-03156a88d290-d303-4223-97a8-367c619c055c12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0315TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 7 package rows20250331_38afa73c-7c87-440d-bece-f268e8e4a44c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSN38afa73c-7c87-440d-bece-f268e8e4a44c13
198241temazepam 15 MG Oral CapsuleSCD38afa73c-7c87-440d-bece-f268e8e4a44c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0315-17133503150120 CAPSULE in 1 BOTTLE (71335-0315-1) 20 capsule2018-06-210000-00-00NoNoCurrent
71335-0315-27133503150230 CAPSULE in 1 BOTTLE (71335-0315-2) 30 capsule2018-03-060000-00-00NoNoCurrent
71335-0315-37133503150360 CAPSULE in 1 BOTTLE (71335-0315-3) 60 capsule2018-02-190000-00-00NoNoCurrent
71335-0315-47133503150490 CAPSULE in 1 BOTTLE (71335-0315-4) 90 capsule2018-04-200000-00-00NoNoCurrent
71335-0315-57133503150528 CAPSULE in 1 BOTTLE (71335-0315-5) 28 capsule2021-12-270000-00-00NoNoCurrent
71335-0315-671335031506120 CAPSULE in 1 BOTTLE (71335-0315-6) 120 capsule2021-12-270000-00-00NoNoCurrent
71335-0315-771335031507100 CAPSULE in 1 BOTTLE (71335-0315-7) 100 capsule2021-12-270000-00-00NoNoCurrent