FDA.reportPublic FDA data

doxepin

Product NDC
72578-181
11-digit product format
725780181
Labeler code
72578
Product ID
72578-181_d569143c-aee2-4e03-988d-1ef10950e7ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA202761
Marketing category
ANDA
Marketing start
2024-06-30
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
72578-181-01doxepin100 in 1 BOTTLETABLET1002
72578-181-05doxepin500 in 1 BOTTLETABLET5002
72578-181-06doxepin30 in 1 BOTTLETABLET302
72578-181-10doxepin1000 in 1 BOTTLETABLET10002
72578-181-16doxepin90 in 1 BOTTLETABLET902
72578-181-77doxepin10 in 1 CARTONTABLET102
72578-181-77doxepin10 in 1 BLISTER PACKTABLET102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-181-06EA - Each72578-1816610f8b6-151d-48a3-8532-f9a06f6af3e312025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-181DOXEPIN TABLET [VIONA PHARMACEUTICALS INC]2Current NDC, 7 package rows20250110_3377541d-db46-4fd9-9a4b-faa5f6108e67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966787doxepin 3 MG Oral TabletPSN3377541d-db46-4fd9-9a4b-faa5f6108e672
966793doxepin 6 MG Oral TabletPSN3377541d-db46-4fd9-9a4b-faa5f6108e672
966787doxepin 3 MG Oral TabletSCD3377541d-db46-4fd9-9a4b-faa5f6108e672
966793doxepin 6 MG Oral TabletSCD3377541d-db46-4fd9-9a4b-faa5f6108e672
966787doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral TabletSY3377541d-db46-4fd9-9a4b-faa5f6108e672
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSY3377541d-db46-4fd9-9a4b-faa5f6108e672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-181-0172578018101100 TABLET in 1 BOTTLE (72578-181-01) 100 tablet2024-06-30NoNoHistorical
72578-181-0572578018105500 TABLET in 1 BOTTLE (72578-181-05) 500 tablet2024-06-30NoNoHistorical
72578-181-067257801810630 TABLET in 1 BOTTLE (72578-181-06) 30 tablet2024-06-30NoNoHistorical
72578-181-10725780181101000 TABLET in 1 BOTTLE (72578-181-10) 1000 tablet2024-06-30NoNoHistorical
72578-181-167257801811690 TABLET in 1 BOTTLE (72578-181-16) 90 tablet2024-06-30NoNoHistorical
72578-181-777257801817710 BLISTER PACK in 1 CARTON (72578-181-77) / 10 TABLET in 1 BLISTER PACK10 blister pack2024-06-30NoNoHistorical