FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
49884-222
11-digit product format
498840222
Labeler code
49884
Product ID
49884-222_75a2a220-95ff-4c6a-aa58-15e3352b6e7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA071422
Marketing category
ANDA
Marketing start
1987-11-09
Substance
DOXEPIN HYDROCHLORIDE
Active strength
150 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 HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000064

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
49884-222-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE10029
49884-222-03Doxepin Hydrochloride50 in 1 BOTTLECAPSULE5029
49884-222-05Doxepin Hydrochloride500 in 1 BOTTLECAPSULE50029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-222-01EA - Each49884-222dd54443a-ea8f-46b5-94c3-c193dcba1c9c12012-07-24
49884-222-03EA - Each49884-222f59c4119-b6c7-4ec8-b663-9af83ae837af12012-07-24
49884-222-05EA - Each49884-22226a93056-8a3b-4591-81f3-af14ba7610af12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC]17
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
D&C ORANGE NO. 10INACTIVE INGREDIENTYUW2S48521DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-222DOXEPIN HYDROCHLORIDE CAPSULE [ENDO USA, INC.]29Current NDC, Legacy NDC, 3 package rows20241215_71cff7cd-0410-4194-9cdd-af404a869edd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000064doxepin HCl 150 MG Oral CapsulePSN71cff7cd-0410-4194-9cdd-af404a869edd29
1000064doxepin 150 MG Oral CapsuleSCD71cff7cd-0410-4194-9cdd-af404a869edd29
1000064doxepin (as doxepin HCl) 150 MG Oral CapsuleSY71cff7cd-0410-4194-9cdd-af404a869edd29
1000064doxepin HCl 150 MG Oral CapsulePSN0d981fbd-3605-417b-91d7-799b21c1a9e317
1000064doxepin 150 MG Oral CapsuleSCD0d981fbd-3605-417b-91d7-799b21c1a9e317
1000064doxepin (as doxepin HCl) 150 MG Oral CapsuleSY0d981fbd-3605-417b-91d7-799b21c1a9e317
1000048doxepin HCl 10 MG Oral CapsulePSNef113645-b1a0-4327-86a0-9b066f0dd1413
1000058doxepin HCl 100 MG Oral CapsulePSNef113645-b1a0-4327-86a0-9b066f0dd1413
1000064doxepin HCl 150 MG Oral CapsulePSNef113645-b1a0-4327-86a0-9b066f0dd1413
1000070doxepin HCl 25 MG Oral CapsulePSNef113645-b1a0-4327-86a0-9b066f0dd1413
1000076doxepin HCl 50 MG Oral CapsulePSNef113645-b1a0-4327-86a0-9b066f0dd1413
1000097doxepin HCl 75 MG Oral CapsulePSNef113645-b1a0-4327-86a0-9b066f0dd1413
1000048doxepin 10 MG Oral CapsuleSCDef113645-b1a0-4327-86a0-9b066f0dd1413
1000058doxepin 100 MG Oral CapsuleSCDef113645-b1a0-4327-86a0-9b066f0dd1413
1000064doxepin 150 MG Oral CapsuleSCDef113645-b1a0-4327-86a0-9b066f0dd1413
1000070doxepin 25 MG Oral CapsuleSCDef113645-b1a0-4327-86a0-9b066f0dd1413
1000076doxepin 50 MG Oral CapsuleSCDef113645-b1a0-4327-86a0-9b066f0dd1413
1000097doxepin 75 MG Oral CapsuleSCDef113645-b1a0-4327-86a0-9b066f0dd1413
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYef113645-b1a0-4327-86a0-9b066f0dd1413
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYef113645-b1a0-4327-86a0-9b066f0dd1413
1000064doxepin (as doxepin HCl) 150 MG Oral CapsuleSYef113645-b1a0-4327-86a0-9b066f0dd1413
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYef113645-b1a0-4327-86a0-9b066f0dd1413
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYef113645-b1a0-4327-86a0-9b066f0dd1413
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSYef113645-b1a0-4327-86a0-9b066f0dd1413
1000064doxepin HCl 150 MG Oral CapsulePSN9ad86cfb-e91d-4e25-8bbc-fae3891c76d81
1000064doxepin 150 MG Oral CapsuleSCD9ad86cfb-e91d-4e25-8bbc-fae3891c76d81
1000064doxepin (as doxepin HCl) 150 MG Oral CapsuleSY9ad86cfb-e91d-4e25-8bbc-fae3891c76d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-222-0149884022201100 CAPSULE in 1 BOTTLE (49884-222-01) 100 capsule1987-11-090000-00-00NoNoCurrent
49884-222-034988402220350 CAPSULE in 1 BOTTLE (49884-222-03) 50 capsule1987-11-090000-00-00NoNoCurrent
49884-222-0549884022205500 CAPSULE in 1 BOTTLE (49884-222-05) 500 capsule1987-11-090000-00-00NoNoCurrent