FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
21695-441
11-digit product format
216950441
Labeler code
21695
Product ID
21695-441_f6ffd0d8-3451-425e-921e-faae1c1b8ad3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA070789
Marketing category
ANDA
Marketing start
1986-05-13
Marketing end
0000-00-00
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 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
21695-441-302019-09-24C16284748780-1934fe258-4a79-48b1-e053-8cdaa90a720aDOXEPIN HYDROCHLORIDE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-441-30Doxepin Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-441-30EA - Each21695-441374a9e38-e18a-4e15-8193-95395d6ac3b912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxepin HydrochlorideACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
DoxepinACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MDOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
gelatinINACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
SHELLACINACTIVE INGREDIENT46N107B71ODOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-441DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 1 package rows20110517_24dd378e-0ef9-4ef8-8032-f81c1d87b3b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN24dd378e-0ef9-4ef8-8032-f81c1d87b3b82
1000076doxepin HCl 50 MG Oral CapsulePSN24dd378e-0ef9-4ef8-8032-f81c1d87b3b82
1000048doxepin 10 MG Oral CapsuleSCD24dd378e-0ef9-4ef8-8032-f81c1d87b3b82
1000076doxepin 50 MG Oral CapsuleSCD24dd378e-0ef9-4ef8-8032-f81c1d87b3b82
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY24dd378e-0ef9-4ef8-8032-f81c1d87b3b82
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY24dd378e-0ef9-4ef8-8032-f81c1d87b3b82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-441-302169504413030 in 1 BOTTLE, PLASTICHistorical