FDA.reportPublic FDA data

Doxepin hydrochloride

Product NDC
71335-2092
11-digit product format
713352092
Labeler code
71335
Product ID
71335-2092_db2e0d46-5dac-48bd-8aca-4fd5ae1b463b
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
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
71335-2092-1Doxepin hydrochloride30 in 1 BOTTLECAPSULE30101
71335-2092-2Doxepin hydrochloride60 in 1 BOTTLECAPSULE60101
71335-2092-3Doxepin hydrochloride18 in 1 BOTTLECAPSULE18101
71335-2092-4Doxepin hydrochloride90 in 1 BOTTLECAPSULE90101
71335-2092-5Doxepin hydrochloride180 in 1 BOTTLECAPSULE180101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2092-1EA - Each71335-2092428ba07c-2f03-4e76-8b2a-d7747aa0383912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2092DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 5 package rows20231024_0cbf87df-c447-4225-81f5-92c4bc3ef81d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN0cbf87df-c447-4225-81f5-92c4bc3ef81d101
1000048doxepin 10 MG Oral CapsuleSCD0cbf87df-c447-4225-81f5-92c4bc3ef81d101
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY0cbf87df-c447-4225-81f5-92c4bc3ef81d101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2092-17133520920130 CAPSULE in 1 BOTTLE (71335-2092-1) 30 capsule2022-05-170000-00-00NoNoCurrent
71335-2092-27133520920260 CAPSULE in 1 BOTTLE (71335-2092-2) 60 capsule2022-05-170000-00-00NoNoCurrent
71335-2092-37133520920318 CAPSULE in 1 BOTTLE (71335-2092-3) 18 capsule2022-05-170000-00-00NoNoCurrent
71335-2092-47133520920490 CAPSULE in 1 BOTTLE (71335-2092-4) 90 capsule2022-05-170000-00-00NoNoCurrent
71335-2092-571335209205180 CAPSULE in 1 BOTTLE (71335-2092-5) 180 capsule2022-05-170000-00-00NoNoCurrent