Home NDC 67544-136 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 Source provenance: Browse the complete Orange Book source catalog .
Additional Listing Data#
Finished product Yes
Brand name base Temazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEMAZEPAM 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CHB1QD2QSS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198241 Internal RxNorm lookup 198242 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67544-136-10 Temazepam 10 in 1 BOTTLE, PLASTIC CAPSULE 10 2 67544-136-14 Temazepam 14 in 1 BOTTLE, PLASTIC CAPSULE 14 2 67544-136-15 Temazepam 15 in 1 BOTTLE, PLASTIC CAPSULE 15 2 67544-136-20 Temazepam 20 in 1 BOTTLE, PLASTIC CAPSULE 20 2 67544-136-28 Temazepam 28 in 1 BOTTLE, PLASTIC CAPSULE 28 2 67544-136-30 Temazepam 30 in 1 BOTTLE, PLASTIC CAPSULE 30 2 67544-136-45 Temazepam 45 in 1 BOTTLE, PLASTIC CAPSULE 45 2 67544-136-53 Temazepam 60 in 1 BOTTLE, PLASTIC CAPSULE 60 2 67544-136-60 Temazepam 90 in 1 BOTTLE, PLASTIC CAPSULE 90 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TEMAZEPAM ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TEMAZEPAM ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-136 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 9 package rows 20190531_2461dfbd-5704-42f4-bde7-d1461811d898.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67544-136-10 67544013610 10 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-10) 10 capsule 2004-08-26 0000-00-00 No No Current 67544-136-14 67544013614 14 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-14) 14 capsule 2004-08-26 0000-00-00 No No Current 67544-136-15 67544013615 15 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-15) 15 capsule 2004-09-16 0000-00-00 No No Current 67544-136-20 67544013620 20 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-20) 20 capsule 2004-09-01 0000-00-00 No No Current 67544-136-28 67544013628 28 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-28) 28 capsule 2009-08-30 0000-00-00 No No Current 67544-136-30 67544013630 30 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-30) 30 capsule 2004-10-16 0000-00-00 No No Current 67544-136-45 67544013645 45 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-45) 45 capsule 2004-09-01 0000-00-00 No No Current 67544-136-53 67544013653 60 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-53) 60 capsule 2004-10-16 0000-00-00 No No Current 67544-136-60 67544013660 90 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-60) 90 capsule 2004-12-08 0000-00-00 No No Current