FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
71335-0072
11-digit product format
713350072
Labeler code
71335
Product ID
71335-0072_34af79a7-5639-4483-a380-33ad98edb57a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207482
Marketing category
ANDA
Marketing start
2017-06-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0072-12024-05-17C16284748780-11030e365-54a8-111a-e063-dadaa90a10e2Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only
71335-0072-22024-05-17C16284748780-11030e365-54a8-111a-e063-dadaa90a10e2Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only
71335-0072-32024-05-17C16284748780-11030e365-54a8-111a-e063-dadaa90a10e2Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only
71335-0072-42024-05-17C16284748780-11030e365-54a8-111a-e063-dadaa90a10e2Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only
71335-0072-52024-05-17C16284748780-11030e365-54a8-111a-e063-dadaa90a10e2Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only
71335-0072-12024-01-30C16284748780-11030e365-54a8-111a-e063-dadaa90a10e2Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only
71335-0072-22024-01-30C16284748780-11030e365-54a8-111a-e063-dadaa90a10e2Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only
71335-0072-32024-01-30C16284748780-11030e365-54a8-111a-e063-dadaa90a10e2Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only
71335-0072-42024-01-30C16284748780-11030e365-54a8-111a-e063-dadaa90a10e2Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only
71335-0072-52024-01-30C16284748780-11030e365-54a8-111a-e063-dadaa90a10e2Doxepin Hydrochloride Capsules, USP (10 mg, 25 mg, 50 mg, 75 mg and 100 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0072-1Doxepin Hydrochloride30 in 1 BOTTLECAPSULE3013
71335-0072-2Doxepin Hydrochloride60 in 1 BOTTLECAPSULE6013
71335-0072-3Doxepin Hydrochloride18 in 1 BOTTLECAPSULE1813
71335-0072-4Doxepin Hydrochloride90 in 1 BOTTLECAPSULE9013
71335-0072-5Doxepin Hydrochloride180 in 1 BOTTLECAPSULE18013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0072DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 5 package rows20250221_3bc72772-22ae-4f29-97ff-4a552b4df6d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN3bc72772-22ae-4f29-97ff-4a552b4df6d013
1000048doxepin 10 MG Oral CapsuleSCD3bc72772-22ae-4f29-97ff-4a552b4df6d013
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY3bc72772-22ae-4f29-97ff-4a552b4df6d013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0072-17133500720130 CAPSULE in 1 BOTTLE (71335-0072-1) 30 capsule2020-01-220000-00-00NoNoCurrent
71335-0072-27133500720260 CAPSULE in 1 BOTTLE (71335-0072-2) 60 capsule2025-01-280000-00-00NoNoCurrent
71335-0072-37133500720318 CAPSULE in 1 BOTTLE (71335-0072-3) 18 capsule2025-01-280000-00-00NoNoCurrent
71335-0072-47133500720490 CAPSULE in 1 BOTTLE (71335-0072-4) 90 capsule2025-01-280000-00-00NoNoCurrent
71335-0072-571335007205180 CAPSULE in 1 BOTTLE (71335-0072-5) 180 capsule2025-01-280000-00-00NoNoCurrent