FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
42806-532
11-digit product format
428060532
Labeler code
42806
Product ID
42806-532_a5adf083-8dd9-4482-a3f1-589ade22b653
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA210675
Marketing category
ANDA
Marketing start
2022-03-03
Substance
DOXEPIN HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 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
42806-532-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1005
42806-532-10Doxepin Hydrochloride1000 in 1 BOTTLECAPSULE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-532DOXEPIN HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]4Current NDC, Legacy NDC, 2 package rows20221230_5f0f6fee-2497-4915-b58b-bf369efcfd79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN5f0f6fee-2497-4915-b58b-bf369efcfd795
1000058doxepin HCl 100 MG Oral CapsulePSN5f0f6fee-2497-4915-b58b-bf369efcfd795
1000070doxepin HCl 25 MG Oral CapsulePSN5f0f6fee-2497-4915-b58b-bf369efcfd795
1000076doxepin HCl 50 MG Oral CapsulePSN5f0f6fee-2497-4915-b58b-bf369efcfd795
1000097doxepin HCl 75 MG Oral CapsulePSN5f0f6fee-2497-4915-b58b-bf369efcfd795
1000048doxepin 10 MG Oral CapsuleSCD5f0f6fee-2497-4915-b58b-bf369efcfd795
1000058doxepin 100 MG Oral CapsuleSCD5f0f6fee-2497-4915-b58b-bf369efcfd795
1000070doxepin 25 MG Oral CapsuleSCD5f0f6fee-2497-4915-b58b-bf369efcfd795
1000076doxepin 50 MG Oral CapsuleSCD5f0f6fee-2497-4915-b58b-bf369efcfd795
1000097doxepin 75 MG Oral CapsuleSCD5f0f6fee-2497-4915-b58b-bf369efcfd795
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY5f0f6fee-2497-4915-b58b-bf369efcfd795
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY5f0f6fee-2497-4915-b58b-bf369efcfd795
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY5f0f6fee-2497-4915-b58b-bf369efcfd795
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY5f0f6fee-2497-4915-b58b-bf369efcfd795
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY5f0f6fee-2497-4915-b58b-bf369efcfd795

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-532-0142806053201100 CAPSULE in 1 BOTTLE (42806-532-01) 100 capsule2022-03-030000-00-00NoNoCurrent
42806-532-10428060532101000 CAPSULE in 1 BOTTLE (42806-532-10) 1000 capsule2022-03-030000-00-00NoNoCurrent