temazepam

Product NDC
35356-821
11-digit product format
353560821
Labeler code
35356
Product ID
35356-821_9e03936a-288e-4a8b-a196-a3361912bed3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA071457
Marketing category
ANDA
Marketing start
2012-06-28
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
23 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-821-30EA - Each35356-82196a972b4-aac7-4117-8607-9da191c617ed12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
temazepamACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
alcoholINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
gelatinINACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
magnesium stearateINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
shellacINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
starch, cornINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-821TEMAZEPAM CAPSULE [QUALITY CARE PRODUCTS LLC]3955Legacy NDC20241213_bcfd6a3d-66eb-4844-bede-6ec671985b2c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-821-303535608213030 CAPSULE in 1 BOTTLE (35356-821-30) 30 capsule2012-06-280000-00-00NoNoCurrent