FDA.reportPublic FDA data

DOXEPIN HYDROCHLORIDE

Product NDC
71335-2647
11-digit product format
713352647
Labeler code
71335
Product ID
71335-2647_73479b35-852c-4091-82e1-7743c681582a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215076
Marketing category
ANDA
Marketing start
2021-04-23
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
71335-2647-1DOXEPIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE302
71335-2647-2DOXEPIN HYDROCHLORIDE60 in 1 BOTTLECAPSULE602
71335-2647-3DOXEPIN HYDROCHLORIDE18 in 1 BOTTLECAPSULE182
71335-2647-4DOXEPIN HYDROCHLORIDE90 in 1 BOTTLECAPSULE902
71335-2647-5DOXEPIN HYDROCHLORIDE180 in 1 BOTTLECAPSULE1802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN09a70f17-f934-4b4b-9277-6351d906ab472
1000048doxepin 10 MG Oral CapsuleSCD09a70f17-f934-4b4b-9277-6351d906ab472
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY09a70f17-f934-4b4b-9277-6351d906ab472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2647-17133526470130 CAPSULE in 1 BOTTLE (71335-2647-1) 30 capsule2025-06-03NoNoHistorical
71335-2647-27133526470260 CAPSULE in 1 BOTTLE (71335-2647-2) 60 capsule2025-06-03NoNoHistorical
71335-2647-37133526470318 CAPSULE in 1 BOTTLE (71335-2647-3) 18 capsule2025-06-03NoNoHistorical
71335-2647-47133526470490 CAPSULE in 1 BOTTLE (71335-2647-4) 90 capsule2025-06-03NoNoHistorical
71335-2647-571335264705180 CAPSULE in 1 BOTTLE (71335-2647-5) 180 capsule2025-06-03NoNoHistorical