FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
72789-334
11-digit product format
727890334
Labeler code
72789
Product ID
72789-334_436c46ab-0e41-2983-e063-6394a90ad90d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA213474
Marketing category
ANDA
Marketing start
2021-05-01
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
Rxcui1000048, 1000058, 1000070, 1000076, 1000097

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
72789-334-30Doxepin Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-334-01EA - Each72789-334270ea68e-dcc8-4851-a57b-f0a73b88df0912023-09-05
72789-334-30EA - Each72789-334b6b0c6b9-4aa4-40f7-89c2-57b74e05b55112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-334DOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]6Current NDC, 1 package rows20240119_8f7e9677-cc84-414b-8eb8-33993d285bb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN8f7e9677-cc84-414b-8eb8-33993d285bb310
1000058doxepin HCl 100 MG Oral CapsulePSN8f7e9677-cc84-414b-8eb8-33993d285bb310
1000070doxepin HCl 25 MG Oral CapsulePSN8f7e9677-cc84-414b-8eb8-33993d285bb310
1000076doxepin HCl 50 MG Oral CapsulePSN8f7e9677-cc84-414b-8eb8-33993d285bb310
1000097doxepin HCl 75 MG Oral CapsulePSN8f7e9677-cc84-414b-8eb8-33993d285bb310
1000048doxepin 10 MG Oral CapsuleSCD8f7e9677-cc84-414b-8eb8-33993d285bb310
1000058doxepin 100 MG Oral CapsuleSCD8f7e9677-cc84-414b-8eb8-33993d285bb310
1000070doxepin 25 MG Oral CapsuleSCD8f7e9677-cc84-414b-8eb8-33993d285bb310
1000076doxepin 50 MG Oral CapsuleSCD8f7e9677-cc84-414b-8eb8-33993d285bb310
1000097doxepin 75 MG Oral CapsuleSCD8f7e9677-cc84-414b-8eb8-33993d285bb310
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY8f7e9677-cc84-414b-8eb8-33993d285bb310
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY8f7e9677-cc84-414b-8eb8-33993d285bb310
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY8f7e9677-cc84-414b-8eb8-33993d285bb310
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY8f7e9677-cc84-414b-8eb8-33993d285bb310
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY8f7e9677-cc84-414b-8eb8-33993d285bb310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-334-307278903343030 CAPSULE in 1 BOTTLE, PLASTIC (72789-334-30) 30 capsule2023-07-28NoNoHistorical