FDA.reportPublic FDA data

DOXEPIN HYDROCHLORIDE

Product NDC
80425-0411
11-digit product format
804250411
Labeler code
80425
Product ID
80425-0411_1cec7bc1-f68c-f85f-e063-6294a90ab05d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA215076
Marketing category
ANDA
Marketing start
2024-07-10
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
80425-0411-1DOXEPIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE301
80425-0411-2DOXEPIN HYDROCHLORIDE60 in 1 BOTTLECAPSULE601
80425-0411-3DOXEPIN HYDROCHLORIDE90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0411-1EA - Each80425-04111d96060c-8f83-4952-837b-c61b3d83079312024-08-12
80425-0411-2EA - Each80425-04113878b1e1-00e4-482d-ba7d-4215a136d74c12024-08-12
80425-0411-3EA - Each80425-041125c2a40d-36aa-4b33-8978-a487cc9192a912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0411DOXEPIN HYDROCHLORIDE CAPSULE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240711_1cec730e-3218-ddf6-e063-6294a90a916e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSN1cec730e-3218-ddf6-e063-6294a90a916e1
1000070doxepin 25 MG Oral CapsuleSCD1cec730e-3218-ddf6-e063-6294a90a916e1
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY1cec730e-3218-ddf6-e063-6294a90a916e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0411-18042504110130 CAPSULE in 1 BOTTLE (80425-0411-1) 30 capsule2024-07-10NoNoHistorical
80425-0411-28042504110260 CAPSULE in 1 BOTTLE (80425-0411-2) 60 capsule2024-07-10NoNoHistorical
80425-0411-38042504110390 CAPSULE in 1 BOTTLE (80425-0411-3) 90 capsule2024-07-10NoNoHistorical