FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
10267-5061
11-digit product format
102675061
Labeler code
10267
Product ID
10267-5061_abbf7078-a013-4e1a-e053-2995a90a792d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacal Corp.
Application
ANDA213474
Marketing category
ANDA
Marketing start
2021-01-24
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
10267-5061-4Doxepin Hydrochloride1000 in 1 BOTTLECAPSULE10001
10267-5061-9Doxepin Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10267-5061DOXEPIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACAL CORP.]1Current NDC, Legacy NDC, 2 package rows20210125_abbf7078-a012-4e1a-e053-2995a90a792d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNabbf7078-a012-4e1a-e053-2995a90a792d1
1000058doxepin HCl 100 MG Oral CapsulePSNabbf7078-a012-4e1a-e053-2995a90a792d1
1000070doxepin HCl 25 MG Oral CapsulePSNabbf7078-a012-4e1a-e053-2995a90a792d1
1000076doxepin HCl 50 MG Oral CapsulePSNabbf7078-a012-4e1a-e053-2995a90a792d1
1000097doxepin HCl 75 MG Oral CapsulePSNabbf7078-a012-4e1a-e053-2995a90a792d1
1000048doxepin 10 MG Oral CapsuleSCDabbf7078-a012-4e1a-e053-2995a90a792d1
1000058doxepin 100 MG Oral CapsuleSCDabbf7078-a012-4e1a-e053-2995a90a792d1
1000070doxepin 25 MG Oral CapsuleSCDabbf7078-a012-4e1a-e053-2995a90a792d1
1000076doxepin 50 MG Oral CapsuleSCDabbf7078-a012-4e1a-e053-2995a90a792d1
1000097doxepin 75 MG Oral CapsuleSCDabbf7078-a012-4e1a-e053-2995a90a792d1
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYabbf7078-a012-4e1a-e053-2995a90a792d1
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYabbf7078-a012-4e1a-e053-2995a90a792d1
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYabbf7078-a012-4e1a-e053-2995a90a792d1
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYabbf7078-a012-4e1a-e053-2995a90a792d1
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSYabbf7078-a012-4e1a-e053-2995a90a792d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10267-5061-4102675061041000 CAPSULE in 1 BOTTLE (10267-5061-4) 1000 capsule2021-01-240000-00-00NoNoCurrent
10267-5061-91026750610990 CAPSULE in 1 BOTTLE (10267-5061-9) 90 capsule2021-01-240000-00-00NoNoCurrent