FDA.reportPublic FDA data

Doxepin hydrochloride

Product NDC
27241-171
11-digit product format
272410171
Labeler code
27241
Product ID
27241-171_4f6891be-49a9-4884-a1ce-35e148c7c156
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA212624
Marketing category
ANDA
Marketing start
2019-12-20
Substance
DOXEPIN HYDROCHLORIDE
Active strength
100 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000048, 1000058, 1000070, 1000076, 1000097

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
27241-171-01Doxepin hydrochloride100 in 1 BOTTLECAPSULE1004
27241-171-10Doxepin hydrochloride1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-171-01EA - Each27241-17194aeccec-5f49-4f50-ba56-1275044fb96812020-03-10
27241-171-10EA - Each27241-1716f835f18-5bf3-4bd7-9fa8-a08701df271f12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-171DOXEPIN HYDROCHLORIDE CAPSULE [AJANTA PHARMA USA INC.]4Current NDC, Legacy NDC, 2 package rows20211126_1513c98c-e7ef-4009-b932-6757048bb86a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN1513c98c-e7ef-4009-b932-6757048bb86a4
1000058doxepin HCl 100 MG Oral CapsulePSN1513c98c-e7ef-4009-b932-6757048bb86a4
1000070doxepin HCl 25 MG Oral CapsulePSN1513c98c-e7ef-4009-b932-6757048bb86a4
1000076doxepin HCl 50 MG Oral CapsulePSN1513c98c-e7ef-4009-b932-6757048bb86a4
1000097doxepin HCl 75 MG Oral CapsulePSN1513c98c-e7ef-4009-b932-6757048bb86a4
1000048doxepin 10 MG Oral CapsuleSCD1513c98c-e7ef-4009-b932-6757048bb86a4
1000058doxepin 100 MG Oral CapsuleSCD1513c98c-e7ef-4009-b932-6757048bb86a4
1000070doxepin 25 MG Oral CapsuleSCD1513c98c-e7ef-4009-b932-6757048bb86a4
1000076doxepin 50 MG Oral CapsuleSCD1513c98c-e7ef-4009-b932-6757048bb86a4
1000097doxepin 75 MG Oral CapsuleSCD1513c98c-e7ef-4009-b932-6757048bb86a4
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY1513c98c-e7ef-4009-b932-6757048bb86a4
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY1513c98c-e7ef-4009-b932-6757048bb86a4
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY1513c98c-e7ef-4009-b932-6757048bb86a4
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY1513c98c-e7ef-4009-b932-6757048bb86a4
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY1513c98c-e7ef-4009-b932-6757048bb86a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-171-0127241017101100 CAPSULE in 1 BOTTLE (27241-171-01) 100 capsule2019-12-200000-00-00NoNoCurrent
27241-171-10272410171101000 CAPSULE in 1 BOTTLE (27241-171-10) 1000 capsule2020-02-200000-00-00NoNoCurrent