FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
63629-5033
11-digit product format
636295033
Labeler code
63629
Product ID
63629-5033_c7bcdac5-b245-4e00-b92d-5134fc2f5e03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070791
Marketing category
ANDA
Marketing start
1986-05-13
Substance
DOXEPIN HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxepin Hydrochloride
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-5033-12024-10-21C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-22024-10-21C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-32024-10-21C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-42024-10-21C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-52024-10-21C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-12024-01-30C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-22024-01-30C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-32024-01-30C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-42024-01-30C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-52024-01-30C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-12020-10-16C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-22020-10-16C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-32020-10-16C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-42020-10-16C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-52020-10-16C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-12020-01-31C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-22020-01-31C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-32020-01-31C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-42020-01-31C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*
63629-5033-52020-01-31C16284748780-19d75b9d0-e794-f424-e053-dadaa90a57ceDoxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5033-1Doxepin Hydrochloride30 in 1 BOTTLECAPSULE301015
63629-5033-2Doxepin Hydrochloride60 in 1 BOTTLECAPSULE601015
63629-5033-3Doxepin Hydrochloride28 in 1 BOTTLECAPSULE281015
63629-5033-4Doxepin Hydrochloride18 in 1 BOTTLECAPSULE181015
63629-5033-5Doxepin Hydrochloride90 in 1 BOTTLECAPSULE901015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5033DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1014Current NDC, Legacy NDC, 5 package rows20241023_c577af7c-2405-4454-a169-5b6a4fa0c7bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSNc577af7c-2405-4454-a169-5b6a4fa0c7bf1015
1000070doxepin 25 MG Oral CapsuleSCDc577af7c-2405-4454-a169-5b6a4fa0c7bf1015
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYc577af7c-2405-4454-a169-5b6a4fa0c7bf1015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5033-16362950330130 CAPSULE in 1 BOTTLE (63629-5033-1) 30 capsule2013-06-120000-00-00NoNoCurrent
63629-5033-26362950330260 CAPSULE in 1 BOTTLE (63629-5033-2) 60 capsule2016-06-020000-00-00NoNoCurrent
63629-5033-36362950330328 CAPSULE in 1 BOTTLE (63629-5033-3) 28 capsule2024-10-080000-00-00NoNoCurrent
63629-5033-46362950330418 CAPSULE in 1 BOTTLE (63629-5033-4) 18 capsule2024-10-080000-00-00NoNoCurrent
63629-5033-56362950330590 CAPSULE in 1 BOTTLE (63629-5033-5) 90 capsule2024-10-080000-00-00NoNoCurrent