FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
55801-527
11-digit product format
558010527
Labeler code
55801
Product ID
55801-527_897d1512-3e1a-469e-bcb9-131e514ed562
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Appco Pharma LLC
Application
ANDA214908
Marketing category
ANDA
Marketing start
2021-06-01
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
55801-527-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1004
55801-527-02Doxepin Hydrochloride500 in 1 BOTTLECAPSULE5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55801-527DOXEPIN HYDROCHLORIDE CAPSULE DOXEPIN HYDROCHLORIDE (DOXEPN HYDROCHLORIDE) CAPSULE [APPCO PHARMA LLC]4Current NDC, Legacy NDC, 2 package rows20210601_abf4c515-8888-4733-80a0-fd4e1cdb84a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000058doxepin HCl 100 MG Oral CapsulePSNabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000070doxepin HCl 25 MG Oral CapsulePSNabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000076doxepin HCl 50 MG Oral CapsulePSNabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000097doxepin HCl 75 MG Oral CapsulePSNabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000048doxepin 10 MG Oral CapsuleSCDabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000058doxepin 100 MG Oral CapsuleSCDabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000070doxepin 25 MG Oral CapsuleSCDabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000076doxepin 50 MG Oral CapsuleSCDabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000097doxepin 75 MG Oral CapsuleSCDabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYabf4c515-8888-4733-80a0-fd4e1cdb84a24
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSYabf4c515-8888-4733-80a0-fd4e1cdb84a24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55801-527-0155801052701100 CAPSULE in 1 BOTTLE (55801-527-01) 100 capsule2021-06-010000-00-00NoNoCurrent
55801-527-0255801052702500 CAPSULE in 1 BOTTLE (55801-527-02) 500 capsule2021-06-010000-00-00NoNoCurrent