FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
71921-163
11-digit product format
719210163
Labeler code
71921
Product ID
71921-163_ccbb860e-6367-5114-e053-2a95a90abfb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
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
71921-163-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-163-01EA - Each71921-163f3ef6981-219e-4798-92b7-cf58995b173c12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-163DOXEPIN HYDROCHLORIDE CAPSULE [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]3Current NDC, Legacy NDC, 1 package rows20210925_b787a283-f882-e1f0-e053-2a95a90a8975.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSNec948b3d-4853-41bb-9f01-faf28fe369e5103
1000070doxepin 25 MG Oral CapsuleSCDec948b3d-4853-41bb-9f01-faf28fe369e5103
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYec948b3d-4853-41bb-9f01-faf28fe369e5103
1000070doxepin HCl 25 MG Oral CapsulePSN6e22050f-95ee-410a-b770-0c32fb8b321b100
1000070doxepin 25 MG Oral CapsuleSCD6e22050f-95ee-410a-b770-0c32fb8b321b100
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY6e22050f-95ee-410a-b770-0c32fb8b321b100
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
1000048doxepin HCl 10 MG Oral CapsulePSNb787a283-f882-e1f0-e053-2a95a90a89753
1000058doxepin HCl 100 MG Oral CapsulePSNb787a283-f882-e1f0-e053-2a95a90a89753
1000070doxepin HCl 25 MG Oral CapsulePSNb787a283-f882-e1f0-e053-2a95a90a89753
1000076doxepin HCl 50 MG Oral CapsulePSNb787a283-f882-e1f0-e053-2a95a90a89753
1000097doxepin HCl 75 MG Oral CapsulePSNb787a283-f882-e1f0-e053-2a95a90a89753
1000048doxepin 10 MG Oral CapsuleSCDb787a283-f882-e1f0-e053-2a95a90a89753
1000058doxepin 100 MG Oral CapsuleSCDb787a283-f882-e1f0-e053-2a95a90a89753
1000070doxepin 25 MG Oral CapsuleSCDb787a283-f882-e1f0-e053-2a95a90a89753
1000076doxepin 50 MG Oral CapsuleSCDb787a283-f882-e1f0-e053-2a95a90a89753
1000097doxepin 75 MG Oral CapsuleSCDb787a283-f882-e1f0-e053-2a95a90a89753
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYb787a283-f882-e1f0-e053-2a95a90a89753
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYb787a283-f882-e1f0-e053-2a95a90a89753
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYb787a283-f882-e1f0-e053-2a95a90a89753
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYb787a283-f882-e1f0-e053-2a95a90a89753
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSYb787a283-f882-e1f0-e053-2a95a90a89753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71921-163-0171921016301100 CAPSULE in 1 BOTTLE (71921-163-01) 100 capsule2021-05-010000-00-00NoNoCurrent