doxepin hydrochloride

Product NDC
44183-103
11-digit product format
441830103
Labeler code
44183
Product ID
44183-103_db184464-82a3-4710-a6aa-6a1c437a7bfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven
Application
NDA022036
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-08-01
Substance
DOXEPIN HYDROCHLORIDE
Active strength
3 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 HYDROCHLORIDE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui966787, 966793

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44183-103-30doxepin hydrochloride30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44183-103-30EA - Each44183-1039255abf1-27dc-49b7-9516-9d98e650769a12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44183-103DOXEPIN HYDROCHLORIDE TABLET [CURRAX PHARMACEUTICALS LLC DBA CYPRESS, HAWTHORN, MACOVEN]3Current NDC, Legacy NDC, 1 package rows20220121_5b4dba99-6b66-4091-94f1-bf5f021c688a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966787doxepin 3 MG Oral TabletPSN5b4dba99-6b66-4091-94f1-bf5f021c688a4
966793doxepin 6 MG Oral TabletPSN5b4dba99-6b66-4091-94f1-bf5f021c688a4
966787doxepin 3 MG Oral TabletSCD5b4dba99-6b66-4091-94f1-bf5f021c688a4
966793doxepin 6 MG Oral TabletSCD5b4dba99-6b66-4091-94f1-bf5f021c688a4
966787doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral TabletSY5b4dba99-6b66-4091-94f1-bf5f021c688a4
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSY5b4dba99-6b66-4091-94f1-bf5f021c688a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44183-103-304418301033030 TABLET in 1 BOTTLE (44183-103-30) 30 tablet2010-08-010000-00-00NoNoCurrent