FDA.reportPublic FDA data

Doxepin hydrochloride

Product NDC
82804-011
11-digit product format
828040011
Labeler code
82804
Product ID
82804-011_7cfbb3d0-f19f-4977-ad0f-77676a8c6f83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA212624
Marketing category
ANDA
Marketing start
2019-12-20
Substance
DOXEPIN HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000070

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
82804-011-30Doxepin hydrochloride30 in 1 BOTTLECAPSULE301
82804-011-60Doxepin hydrochloride60 in 1 BOTTLECAPSULE601
82804-011-90Doxepin hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-011DOXEPIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1Current NDC, 3 package rows20230923_7cfbb3d0-f19f-4977-ad0f-77676a8c6f83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSN7cfbb3d0-f19f-4977-ad0f-77676a8c6f831
1000070doxepin 25 MG Oral CapsuleSCD7cfbb3d0-f19f-4977-ad0f-77676a8c6f831
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY7cfbb3d0-f19f-4977-ad0f-77676a8c6f831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-011-308280400113030 CAPSULE in 1 BOTTLE (82804-011-30) 30 capsule2023-09-21NoNoCurrent
82804-011-608280400116060 CAPSULE in 1 BOTTLE (82804-011-60) 60 capsule2023-09-21NoNoCurrent
82804-011-908280400119090 CAPSULE in 1 BOTTLE (82804-011-90) 90 capsule2023-09-21NoNoCurrent