Doxepin Hydrochloride

Product NDC
70518-4238
11-digit product format
705184238
Labeler code
70518
Product ID
70518-4238_4006d7dd-8a75-241d-e063-6394a90adde1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA215113
Marketing category
ANDA
Marketing start
2024-12-13
Substance
DOXEPIN HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000070

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
70518-4238-0Doxepin Hydrochloride30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4238DOXEPIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]1Current NDC, 1 package rows20241215_d29a8c70-cf1c-4bf8-bb87-1c80babce64e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSNd29a8c70-cf1c-4bf8-bb87-1c80babce64e2
1000070doxepin 25 MG Oral CapsuleSCDd29a8c70-cf1c-4bf8-bb87-1c80babce64e2
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYd29a8c70-cf1c-4bf8-bb87-1c80babce64e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4238-07051842380030 CAPSULE in 1 BLISTER PACK (70518-4238-0) 30 capsule2024-12-13NoNoHistorical