Doxepin Hydrochloride

Product NDC
50090-7819
11-digit product format
500907819
Labeler code
50090
Product ID
50090-7819_51e41985-0be0-4965-8562-d1df183e2575
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA215113
Marketing category
ANDA
Marketing start
2022-06-27
Substance
DOXEPIN HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000076

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
50090-7819-1Doxepin Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7819-1EA - Each50090-781932c0d745-172c-47ef-be0f-9bcc6f7d140112026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000076doxepin HCl 50 MG Oral CapsulePSNe0460c02-3dae-4b19-845c-2ffcfb587f6d1
1000076doxepin 50 MG Oral CapsuleSCDe0460c02-3dae-4b19-845c-2ffcfb587f6d1
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYe0460c02-3dae-4b19-845c-2ffcfb587f6d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7819-15009078190130 CAPSULE in 1 BOTTLE (50090-7819-1) 30 capsule2025-12-11NoNoHistorical