FDA.reportPublic FDA data

Doxepin hydrochloride

Product NDC
72205-052
11-digit product format
722050052
Labeler code
72205
Product ID
72205-052_97c3bda8-3dbe-4c7a-aee9-00418c11d24c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA214823
Marketing category
ANDA
Marketing start
2023-04-05
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-052-05Doxepin hydrochloride500 in 1 BOTTLETABLET5002
72205-052-30Doxepin hydrochloride30 in 1 BOTTLETABLET302
72205-052-91Doxepin hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-052-30EA - Each72205-0523e57f738-d60e-401d-81cd-f68ab9927c8212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-052DOXEPIN HYDROCHLORIDE TABLET [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, 3 package rows20241017_96086fd8-8fa3-4a2b-ac12-fe1a3ad4f384.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966787doxepin 3 MG Oral TabletPSN00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966793doxepin 6 MG Oral TabletPSN00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966787doxepin 3 MG Oral TabletSCD00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966793doxepin 6 MG Oral TabletSCD00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966787doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral TabletSY00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSY00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966787doxepin 3 MG Oral TabletPSN96086fd8-8fa3-4a2b-ac12-fe1a3ad4f3842
966793doxepin 6 MG Oral TabletPSN96086fd8-8fa3-4a2b-ac12-fe1a3ad4f3842
966787doxepin 3 MG Oral TabletSCD96086fd8-8fa3-4a2b-ac12-fe1a3ad4f3842
966793doxepin 6 MG Oral TabletSCD96086fd8-8fa3-4a2b-ac12-fe1a3ad4f3842
966787doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral TabletSY96086fd8-8fa3-4a2b-ac12-fe1a3ad4f3842
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSY96086fd8-8fa3-4a2b-ac12-fe1a3ad4f3842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-052-0572205005205500 TABLET in 1 BOTTLE (72205-052-05) 500 tablet2023-04-05NoNoCurrent
72205-052-307220500523030 TABLET in 1 BOTTLE (72205-052-30) 30 tablet2023-04-05NoNoCurrent
72205-052-9172205005291100 TABLET in 1 BOTTLE (72205-052-91) 100 tablet2023-04-05NoNoCurrent