FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
81469-417
11-digit product format
814690417
Labeler code
81469
Product ID
81469-417_55da757c-42d2-4963-b06f-def9f18a423f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
First Nation Group, LLC
Application
ANDA215710
Marketing category
ANDA
Marketing start
2023-01-11
Substance
DOXEPIN HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000048, 1000058, 1000070, 1000076, 1000097

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
81469-417-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1003
81469-417-05Doxepin Hydrochloride500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81469-417-01EA - Each81469-4174ac6ddcb-ea23-45c8-991e-42c43628ba8112023-03-13
81469-417-05EA - Each81469-417fc6303b8-d46f-4814-ba4e-7c070f06d79812023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81469-417DOXEPIN HYDROCHLORIDE CAPSULE [FIRST NATION GROUP, LLC]1Current NDC, Legacy NDC, 2 package rows20230113_3d4f84a4-07a1-4d0e-85f5-dcd43b236a42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000058doxepin HCl 100 MG Oral CapsulePSN3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000070doxepin HCl 25 MG Oral CapsulePSN3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000076doxepin HCl 50 MG Oral CapsulePSN3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000097doxepin HCl 75 MG Oral CapsulePSN3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000048doxepin 10 MG Oral CapsuleSCD3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000058doxepin 100 MG Oral CapsuleSCD3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000070doxepin 25 MG Oral CapsuleSCD3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000076doxepin 50 MG Oral CapsuleSCD3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000097doxepin 75 MG Oral CapsuleSCD3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY3d4f84a4-07a1-4d0e-85f5-dcd43b236a423
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY3d4f84a4-07a1-4d0e-85f5-dcd43b236a423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81469-417-0181469041701100 CAPSULE in 1 BOTTLE (81469-417-01) 100 capsule2023-01-110000-00-00NoNoCurrent
81469-417-0581469041705500 CAPSULE in 1 BOTTLE (81469-417-05) 500 capsule2023-01-110000-00-00NoNoCurrent