FDA.reportPublic FDA data

Doxepin

Product NDC
72819-161
11-digit product format
728190161
Labeler code
72819
Product ID
72819-161_0e1f91fa-a035-857e-e063-6394a90a68c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Archis Pharma LLC
Application
ANDA202337
Marketing category
ANDA
Marketing start
2022-02-21
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72819-161-03Doxepin30 in 1 BOTTLETABLET, FILM COATED303
72819-161-10Doxepin100 in 1 BOTTLETABLET, FILM COATED1003
72819-161-11Doxepin500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72819-161-03EA - Each72819-161caefaee8-3c14-4140-abad-9b6de4ae559612022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72819-161DOXEPIN TABLET, FILM COATED [ARCHIS PHARMA LLC]3Current NDC, Legacy NDC, 3 package rows20240105_e3eac8e4-224e-4b7b-81d3-071301f914fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966787doxepin 3 MG Oral TabletPSNe3eac8e4-224e-4b7b-81d3-071301f914fa3
966793doxepin 6 MG Oral TabletPSNe3eac8e4-224e-4b7b-81d3-071301f914fa3
966787doxepin 3 MG Oral TabletSCDe3eac8e4-224e-4b7b-81d3-071301f914fa3
966793doxepin 6 MG Oral TabletSCDe3eac8e4-224e-4b7b-81d3-071301f914fa3
966787doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral TabletSYe3eac8e4-224e-4b7b-81d3-071301f914fa3
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSYe3eac8e4-224e-4b7b-81d3-071301f914fa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72819-161-037281901610330 TABLET, FILM COATED in 1 BOTTLE (72819-161-03) 2022-02-210000-00-00NoNoCurrent
72819-161-1072819016110100 TABLET, FILM COATED in 1 BOTTLE (72819-161-10) 2022-02-210000-00-00NoNoCurrent
72819-161-1172819016111500 TABLET, FILM COATED in 1 BOTTLE (72819-161-11) 2022-02-210000-00-00NoNoCurrent