Doxepin Hydrochloride

Product NDC
64725-5375
11-digit product format
647255375
Labeler code
64725
Product ID
64725-5375_1bb4e48b-8113-4789-a602-377dbf517c8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA070791
Marketing category
ANDA
Marketing start
1986-05-13
Marketing end
0000-00-00
Substance
DOXEPIN HYDROCHLORIDE
Active strength
75 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-5375-12019-11-27C16284748780-19855e2a2-3b9d-60a7-e053-dbdaa90a05bd718b6ebd-279e-4de0-ad46-c1d2a25ed19d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-5375-1Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
SHELLACINACTIVE INGREDIENT46N107B71ODOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-5375DOXEPIN HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140927_718b6ebd-279e-4de0-ad46-c1d2a25ed19d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000097doxepin HCl 75 MG Oral CapsulePSN718b6ebd-279e-4de0-ad46-c1d2a25ed19d2
1000097doxepin 75 MG Oral CapsuleSCD718b6ebd-279e-4de0-ad46-c1d2a25ed19d2
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY718b6ebd-279e-4de0-ad46-c1d2a25ed19d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-5375-164725537501100 in 1 BOTTLEHistorical