FDA.reportPublic FDA data

Doxepin hydrochloride

Product NDC
70518-3594
11-digit product format
705183594
Labeler code
70518
Product ID
70518-3594_4f5c2409-3357-cee1-e063-6294a90ae4ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212624
Marketing category
ANDA
Marketing start
2022-12-13
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 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
70518-3594-0Doxepin hydrochloride30 in 1 BLISTER PACKCAPSULE305
70518-3594-1Doxepin hydrochloride30 in 1 BLISTER PACKCAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3594DOXEPIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]2Current NDC, Legacy NDC, 2 package rows20240116_4ecd3b43-b5f1-4cf4-af36-eb214c1a3c60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN4ecd3b43-b5f1-4cf4-af36-eb214c1a3c605
1000048doxepin 10 MG Oral CapsuleSCD4ecd3b43-b5f1-4cf4-af36-eb214c1a3c605
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY4ecd3b43-b5f1-4cf4-af36-eb214c1a3c605

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3594-07051835940030 CAPSULE in 1 BLISTER PACK (70518-3594-0) 30 capsule2022-12-130000-00-00NoNoCurrent
70518-3594-17051835940130 CAPSULE in 1 BLISTER PACK (70518-3594-1) 30 capsule2025-02-07NoNoHistorical