Doxepin Hydrochloride

Product NDC
49884-220
11-digit product format
498840220
Labeler code
49884
Product ID
49884-220_7fd4eccf-6d67-4f6d-b2a5-166c3b25ad1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA071422
Marketing category
ANDA
Marketing start
2017-09-01
Marketing end
0000-00-00
Substance
DOXEPIN HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-220-01EA - Each49884-2208aff3546-dc0f-4bc4-9396-e67e42b1c41512017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-220-0149884022001100 CAPSULE in 1 BOTTLE (49884-220-01) 100 capsule2017-09-010000-00-00NoNoCurrent