FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
72205-091
11-digit product format
722050091
Labeler code
72205
Product ID
72205-091_2b1f0144-65d8-451f-8054-6be1675f102c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA215113
Marketing category
ANDA
Marketing start
2022-06-27
Substance
DOXEPIN HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 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
72205-091-91Doxepin Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1001
72205-091-99Doxepin Hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-091-91EA - Each72205-091b7418c1a-77d1-40b0-a9ea-dbc294e98c6712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-091DOXEPIN HYDROCHLORIDE CAPSULE [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20220629_2b1f0144-65d8-451f-8054-6be1675f102c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000097doxepin HCl 75 MG Oral CapsulePSN5ee0f8e6-df05-4166-a614-77e124db95ae2
1000097doxepin 75 MG Oral CapsuleSCD5ee0f8e6-df05-4166-a614-77e124db95ae2
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY5ee0f8e6-df05-4166-a614-77e124db95ae2
1000048doxepin HCl 10 MG Oral CapsulePSN2b1f0144-65d8-451f-8054-6be1675f102c1
1000058doxepin HCl 100 MG Oral CapsulePSN2b1f0144-65d8-451f-8054-6be1675f102c1
1000070doxepin HCl 25 MG Oral CapsulePSN2b1f0144-65d8-451f-8054-6be1675f102c1
1000076doxepin HCl 50 MG Oral CapsulePSN2b1f0144-65d8-451f-8054-6be1675f102c1
1000097doxepin HCl 75 MG Oral CapsulePSN2b1f0144-65d8-451f-8054-6be1675f102c1
1000048doxepin 10 MG Oral CapsuleSCD2b1f0144-65d8-451f-8054-6be1675f102c1
1000058doxepin 100 MG Oral CapsuleSCD2b1f0144-65d8-451f-8054-6be1675f102c1
1000070doxepin 25 MG Oral CapsuleSCD2b1f0144-65d8-451f-8054-6be1675f102c1
1000076doxepin 50 MG Oral CapsuleSCD2b1f0144-65d8-451f-8054-6be1675f102c1
1000097doxepin 75 MG Oral CapsuleSCD2b1f0144-65d8-451f-8054-6be1675f102c1
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY2b1f0144-65d8-451f-8054-6be1675f102c1
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY2b1f0144-65d8-451f-8054-6be1675f102c1
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY2b1f0144-65d8-451f-8054-6be1675f102c1
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY2b1f0144-65d8-451f-8054-6be1675f102c1
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY2b1f0144-65d8-451f-8054-6be1675f102c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-091-9172205009191100 CAPSULE in 1 BOTTLE, PLASTIC (72205-091-91) 100 capsule2022-06-270000-00-00NoNoCurrent
72205-091-99722050091991000 CAPSULE in 1 BOTTLE, PLASTIC (72205-091-99) 1000 capsule2022-06-270000-00-00NoNoCurrent