FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
71335-2418
11-digit product format
713352418
Labeler code
71335
Product ID
71335-2418_8885944d-8f69-4cc1-b92c-fa15777dcc43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215113
Marketing category
ANDA
Marketing start
2022-06-27
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
71335-2418-1Doxepin Hydrochloride30 in 1 BOTTLECAPSULE30100
71335-2418-2Doxepin Hydrochloride60 in 1 BOTTLECAPSULE60100
71335-2418-3Doxepin Hydrochloride28 in 1 BOTTLECAPSULE28100
71335-2418-4Doxepin Hydrochloride18 in 1 BOTTLECAPSULE18100
71335-2418-5Doxepin Hydrochloride90 in 1 BOTTLECAPSULE90100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2418DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20241114_13da67ec-370c-4647-8440-80fd55f1398e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSN13da67ec-370c-4647-8440-80fd55f1398e100
1000070doxepin 25 MG Oral CapsuleSCD13da67ec-370c-4647-8440-80fd55f1398e100
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY13da67ec-370c-4647-8440-80fd55f1398e100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2418-17133524180130 CAPSULE in 1 BOTTLE (71335-2418-1) 30 capsule2024-11-12NoNoHistorical
71335-2418-27133524180260 CAPSULE in 1 BOTTLE (71335-2418-2) 60 capsule2024-11-12NoNoHistorical
71335-2418-37133524180328 CAPSULE in 1 BOTTLE (71335-2418-3) 28 capsule2024-11-12NoNoHistorical
71335-2418-47133524180418 CAPSULE in 1 BOTTLE (71335-2418-4) 18 capsule2024-11-12NoNoHistorical
71335-2418-57133524180590 CAPSULE in 1 BOTTLE (71335-2418-5) 90 capsule2024-11-12NoNoHistorical