Doxepin hydrochloride

Product NDC
71335-2188
11-digit product format
713352188
Labeler code
71335
Product ID
71335-2188_e065f520-615b-4d20-9652-1c4a96ff001b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212624
Marketing category
ANDA
Marketing start
2019-12-20
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
71335-2188-1Doxepin hydrochloride30 in 1 BOTTLECAPSULE30101
71335-2188-2Doxepin hydrochloride60 in 1 BOTTLECAPSULE60101
71335-2188-3Doxepin hydrochloride28 in 1 BOTTLECAPSULE28101
71335-2188-4Doxepin hydrochloride18 in 1 BOTTLECAPSULE18101
71335-2188-5Doxepin hydrochloride90 in 1 BOTTLECAPSULE90101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2188DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 5 package rows20231117_2cacce3a-4986-44a8-b4aa-6edb076d87bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSN2cacce3a-4986-44a8-b4aa-6edb076d87bf101
1000070doxepin 25 MG Oral CapsuleSCD2cacce3a-4986-44a8-b4aa-6edb076d87bf101
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY2cacce3a-4986-44a8-b4aa-6edb076d87bf101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2188-17133521880130 CAPSULE in 1 BOTTLE (71335-2188-1) 30 capsule2022-11-150000-00-00NoNoCurrent
71335-2188-27133521880260 CAPSULE in 1 BOTTLE (71335-2188-2) 60 capsule2022-11-150000-00-00NoNoCurrent
71335-2188-37133521880328 CAPSULE in 1 BOTTLE (71335-2188-3) 28 capsule2022-11-150000-00-00NoNoCurrent
71335-2188-47133521880418 CAPSULE in 1 BOTTLE (71335-2188-4) 18 capsule2022-11-150000-00-00NoNoCurrent
71335-2188-57133521880590 CAPSULE in 1 BOTTLE (71335-2188-5) 90 capsule2022-11-150000-00-00NoNoCurrent