Doxepin Hydrochloride

Product NDC
67296-2165
11-digit product format
672962165
Labeler code
67296
Product ID
67296-2165_45abebda-9f37-adae-e063-6294a90a811a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA207482
Marketing category
ANDA
Marketing start
2017-06-28
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000048

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
67296-2165-2Doxepin Hydrochloride20 in 1 BOTTLECAPSULE204

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN37451a61-ccb1-57b3-e063-6294a90a25924
1000048doxepin 10 MG Oral CapsuleSCD37451a61-ccb1-57b3-e063-6294a90a25924
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY37451a61-ccb1-57b3-e063-6294a90a25924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2165-26729621650220 CAPSULE in 1 BOTTLE (67296-2165-2) 20 capsule2017-06-28NoNoHistorical