FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
71205-610
11-digit product format
712050610
Labeler code
71205
Product ID
71205-610_23030a80-682e-4757-92bb-4db9f6d2afe6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211603
Marketing category
ANDA
Marketing start
2019-03-27
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
71205-610-30Doxepin Hydrochloride30 in 1 BOTTLECAPSULE302
71205-610-60Doxepin Hydrochloride60 in 1 BOTTLECAPSULE602
71205-610-90Doxepin Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-610-30EA - Each71205-61099a762c3-f3fc-4c64-95d6-d0ab358daa4412022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-610DOXEPIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220513_6ce7fde2-2d47-4238-9beb-555d352f4657.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSN6ce7fde2-2d47-4238-9beb-555d352f46572
1000070doxepin 25 MG Oral CapsuleSCD6ce7fde2-2d47-4238-9beb-555d352f46572
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY6ce7fde2-2d47-4238-9beb-555d352f46572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-610-307120506103030 CAPSULE in 1 BOTTLE (71205-610-30) 30 capsule2021-10-080000-00-00NoNoCurrent
71205-610-607120506106060 CAPSULE in 1 BOTTLE (71205-610-60) 60 capsule2021-10-080000-00-00NoNoCurrent
71205-610-907120506109090 CAPSULE in 1 BOTTLE (71205-610-90) 90 capsule2021-10-080000-00-00NoNoCurrent