FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
72789-220
11-digit product format
727890220
Labeler code
72789
Product ID
72789-220_2ad0418c-56c4-50a0-e063-6394a90a35ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA211603
Marketing category
ANDA
Marketing start
2019-03-27
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
72789-220-30Doxepin Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE309
72789-220-90Doxepin Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-220-30EA - Each72789-220b560d297-fd63-4374-ae54-7e3b52e0221412022-10-06
72789-220-90EA - Each72789-22020601fb2-2116-4532-9b3b-a6e62b9bcc8412024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-220DOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20250105_2bf7d838-6274-4d8a-91cb-b27e1e81d273.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN2bf7d838-6274-4d8a-91cb-b27e1e81d2739
1000048doxepin 10 MG Oral CapsuleSCD2bf7d838-6274-4d8a-91cb-b27e1e81d2739
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY2bf7d838-6274-4d8a-91cb-b27e1e81d2739

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-220-307278902203030 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-30) 30 capsule2021-12-220000-00-00NoNoCurrent
72789-220-907278902209090 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-90) 90 capsule2024-09-06NoNoCurrent