FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
51079-436
11-digit product format
510790436
Labeler code
51079
Product ID
51079-436_3a3b3b4a-148f-1dc5-e063-6394a90a7bdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA070791
Marketing category
ANDA
Marketing start
1998-06-12
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxepin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000048, 1000058, 1000070, 1000076

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
51079-436-01Doxepin Hydrochloride1 in 1 BLISTER PACKCAPSULE112
51079-436-20Doxepin Hydrochloride100 in 1 CARTONCAPSULE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-436-01EA - Each51079-436afa45847-4da1-41c4-94e7-41488fb141f912012-07-24
51079-436-20EA - Each51079-436f9388275-f168-4981-80ee-8340417ac37112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ODOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-436DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]11Current NDC, Legacy NDC, 2 package rows20240920_137a953b-3c48-405f-86a6-ff778cb7f5f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000058doxepin HCl 100 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000070doxepin HCl 25 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000076doxepin HCl 50 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000048doxepin 10 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000058doxepin 100 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000070doxepin 25 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000076doxepin 50 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-436-01510790436011 in 1 BLISTER PACKHistorical
51079-436-2051079043620100 BLISTER PACK in 1 CARTON (51079-436-20) / 1 CAPSULE in 1 BLISTER PACK (51079-436-01) 100 blister pack1998-06-120000-00-00NoNoCurrent