FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
42806-533
11-digit product format
428060533
Labeler code
42806
Product ID
42806-533_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
2017-06-06
Substance
DOXEPIN HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 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
42806-533-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1005
42806-533-10Doxepin Hydrochloride1000 in 1 BOTTLECAPSULE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-533-01EA - Each42806-533b36ae724-59f7-40b7-a3b9-8110fed6cdd912022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-533DOXEPIN 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
42806-533-0142806053301100 CAPSULE in 1 BOTTLE (42806-533-01) 100 capsule2017-06-060000-00-00NoNoCurrent
42806-533-10428060533101000 CAPSULE in 1 BOTTLE (42806-533-10) 1000 capsule2017-06-060000-00-00NoNoCurrent