FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
0904-7055
11-digit product format
009047055
Labeler code
0904
Product ID
0904-7055_b96f2236-46f3-47c4-a658-aa3d30f56b0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA207482
Marketing category
ANDA
Marketing start
2017-06-28
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

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

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
0904-7055-61Doxepin Hydrochloride100 in 1 CARTONCAPSULE1009
0904-7055-61Doxepin Hydrochloride1 in 1 BLISTER PACKCAPSULE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7055-61EA - Each0904-70554f4a5aa6-e5be-4211-8a2c-7480d8a82a4812021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7055DOXEPIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20241222_df3b6be0-6a64-4174-b351-dab2061f290e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNdf3b6be0-6a64-4174-b351-dab2061f290e9
1000058doxepin HCl 100 MG Oral CapsulePSNdf3b6be0-6a64-4174-b351-dab2061f290e9
1000070doxepin HCl 25 MG Oral CapsulePSNdf3b6be0-6a64-4174-b351-dab2061f290e9
1000076doxepin HCl 50 MG Oral CapsulePSNdf3b6be0-6a64-4174-b351-dab2061f290e9
1000048doxepin 10 MG Oral CapsuleSCDdf3b6be0-6a64-4174-b351-dab2061f290e9
1000058doxepin 100 MG Oral CapsuleSCDdf3b6be0-6a64-4174-b351-dab2061f290e9
1000070doxepin 25 MG Oral CapsuleSCDdf3b6be0-6a64-4174-b351-dab2061f290e9
1000076doxepin 50 MG Oral CapsuleSCDdf3b6be0-6a64-4174-b351-dab2061f290e9
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYdf3b6be0-6a64-4174-b351-dab2061f290e9
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYdf3b6be0-6a64-4174-b351-dab2061f290e9
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYdf3b6be0-6a64-4174-b351-dab2061f290e9
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYdf3b6be0-6a64-4174-b351-dab2061f290e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7055-6100904705561100 BLISTER PACK in 1 CARTON (0904-7055-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2017-06-280000-00-00NoNoCurrent