FDA.reportPublic FDA data

NDC 68084-549-11 - Temazepam

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-549
Requested NDC
68084-549-11
Package NDCs from labels
68084-549-11, 68084-549-21
Manufacturer
American Health Packaging
Effective date
2025-11-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temazepam - American Health PackagingAmerican Health Packaging2025-11-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-549-11Temazepam1 in 1 BLISTER PACKCAPSULE110
68084-549-21Temazepam30 in 1 BOX, UNIT-DOSECAPSULE3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-549TEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 2 package rows20240131_a3f06243-fa03-4cbd-951a-144ec43dcdfd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-549-11EA - Each68084-549726f3428-2014-47cd-94bd-bdd0c397fa2112013-02-13
68084-549-21EA - Each68084-549fca83a96-71b3-448d-91b4-b5c1fa7718bb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
ETHYL ACETATEINACTIVE INGREDIENT76845O8NMZTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
SHELLACINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3

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 4 of 246 · 4,917 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer,2pk -Bourbon Peacan and MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a508fad-c7a4-82e8-e063-6294a90a0de12026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Beaded Wristlet - EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f160d3-7e42-ef07-e063-6394a90a6f8f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2ab646-2dba-5111-e063-6394a90acc4f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Strawberry Dream/ Berry BlissALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2b50a2-6ee2-04d4-e063-6294a90a1c652026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Cherry and Honey VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2c11e6-a105-5362-e063-6394a90a132f2026-08-29WarningsExact identifier
unii: 3K9958V90M
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59ef14d6-1a40-ea3c-e063-6394a90af4422026-08-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling PomegranateALCOHOLShenzhen Lantern Scicence Co.,Ltd.597530cb-03f6-b72d-e063-6394a90a0d6c2026-08-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,4pk with Silicone Case,Rosewater/Raspberry Fizz/Strawberry Vanilla/Pink PeonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f1521c-ad5c-e2d6-e063-6394a90a4e2b2026-08-28WarningsExact identifier
unii: 3K9958V90M
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA Inc.5dc007a2-61fa-4115-a82c-1aa489a6bd392026-08-27WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLBreckenridge Pharmaceutical Incbe10b253-d72a-4f57-aa27-94c70ae8aed32026-08-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Surface x Cutie Pals Hand Sanitizer SurpriseALCOHOLI WORLD, LLC2e274b4a-953e-47ce-aa73-81576a4677102026-08-27WarningsExact identifier
unii: 3K9958V90M
Surface x Cutie Pals Hand Sanitizer Cherry PieALCOHOLI WORLD, LLC771fdce8-c633-4592-9bbf-5985c2536f2d2026-08-27WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate RaspberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2a89f4-838e-e3ea-e063-6294a90a1ac22026-08-27WarningsExact identifier
unii: 3K9958V90M
Smart Care LAVENDER VANILLA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.549c6774-a785-4a12-9ff9-9ba17befcc392026-08-27WarningsExact identifier
unii: 3K9958V90M
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.398ca23c-7202-4670-be14-9829675f71742026-08-27WarningsExact identifier
unii: 3K9958V90M
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.