DOXEPIN HYDROCHLORIDE

Product NDC
72189-161
11-digit product format
721890161
Labeler code
72189
Product ID
72189-161_2be91ea1-1f2a-d635-e063-6294a90a4dd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
direct rx
Application
ANDA213063
Marketing category
ANDA
Marketing start
2020-12-01
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
72189-161-30DOXEPIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-161DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250119_b56cdaee-6187-c763-e053-2995a90acc3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSNb56cdaee-6187-c763-e053-2995a90acc3f2
1000070doxepin 25 MG Oral CapsuleSCDb56cdaee-6187-c763-e053-2995a90acc3f2
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYb56cdaee-6187-c763-e053-2995a90acc3f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-161-307218901613030 CAPSULE in 1 BOTTLE (72189-161-30) 30 capsule2020-12-010000-00-00NoNoCurrent