DOXEPIN HYDROCHLORIDE

Product NDC
61919-567
11-digit product format
619190567
Labeler code
61919
Product ID
61919-567_3f616c80-b8cf-320b-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA070791
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
DOXEPIN HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6fcd62d-384f-5faa-05d7-c5d5903c6c43Product name420250515
3d5463a5-d368-9c2b-b40c-0f2b688e406eProduct name920240805
750bc85a-c69c-4145-a865-3f1124677d16Product name320240321
eda77195-5c17-5c7f-a6a7-8c80d2f8ae5fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-567-30DOXEPIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE302
61919-567-60DOXEPIN HYDROCHLORIDE60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-567-60EA - Each61919-56715eaab44-2de9-478b-b84a-3f6be57e0fd312017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71ODOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-567DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]2Legacy NDC, 2 package rows20161021_ab4e12c5-461c-4fb3-857c-6b56547ae102.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSNab4e12c5-461c-4fb3-857c-6b56547ae1022
1000070doxepin 25 MG Oral CapsuleSCDab4e12c5-461c-4fb3-857c-6b56547ae1022
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYab4e12c5-461c-4fb3-857c-6b56547ae1022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-567-306191905673030 in 1 BOTTLEHistorical
61919-567-606191905676060 in 1 BOTTLEHistorical