FDA.reportPublic FDA data

DOXEPIN HYDROCHLORIDE

Product NDC
50090-5286
11-digit product format
500905286
Labeler code
50090
Product ID
50090-5286_21a943cc-60a8-474b-a2af-5a953bc57e61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213063
Marketing category
ANDA
Marketing start
2020-07-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5286-12023-02-07C16284748780-1f386c64a-3076-0266-e053-dadaa90a7c1aDoxepin Hydrochloride Capsules, USP
50090-5286-12023-01-30C16284748780-1f386c64a-3076-0266-e053-dadaa90a7c1aDoxepin Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5286-0DOXEPIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1005
50090-5286-1DOXEPIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5286-1EA - Each50090-528602ef66b8-69c7-41f9-b49b-586864e1f85612024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5286DOXEPIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20240731_55a20aa1-fc9e-487d-9f8d-c4abf77ae2d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000076doxepin HCl 50 MG Oral CapsulePSN55a20aa1-fc9e-487d-9f8d-c4abf77ae2d25
1000076doxepin 50 MG Oral CapsuleSCD55a20aa1-fc9e-487d-9f8d-c4abf77ae2d25
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY55a20aa1-fc9e-487d-9f8d-c4abf77ae2d25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5286-050090528600100 CAPSULE in 1 BOTTLE (50090-5286-0) 100 capsule2020-10-22NoNoCurrent
50090-5286-15009052860130 CAPSULE in 1 BOTTLE (50090-5286-1) 30 capsule2020-10-220000-00-00NoNoCurrent