FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
69238-1172
11-digit product format
692381172
Labeler code
69238
Product ID
69238-1172_0d905a6d-9f40-435d-a39a-f97ce7264b15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA207482
Marketing category
ANDA
Marketing start
2017-06-28
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
69238-1172-1Doxepin Hydrochloride1000 in 1 BOTTLECAPSULE100015
69238-1172-3Doxepin Hydrochloride30 in 1 BOTTLECAPSULE3015
69238-1172-9Doxepin Hydrochloride90 in 1 BOTTLECAPSULE9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1172-1EA - Each69238-1172bf7ddb89-a103-4c88-83c0-966d3a3393cf12017-08-11
69238-1172-9EA - Each69238-1172a470e7a3-6420-4ea8-9124-89fde35ad6a412017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1172DOXEPIN HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]15Current NDC, Legacy NDC, 3 package rows20241210_20bfb8af-7933-4e5c-a2b5-010659d9125b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000058doxepin HCl 100 MG Oral CapsulePSN20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000070doxepin HCl 25 MG Oral CapsulePSN20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000076doxepin HCl 50 MG Oral CapsulePSN20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000097doxepin HCl 75 MG Oral CapsulePSN20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000048doxepin 10 MG Oral CapsuleSCD20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000058doxepin 100 MG Oral CapsuleSCD20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000070doxepin 25 MG Oral CapsuleSCD20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000076doxepin 50 MG Oral CapsuleSCD20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000097doxepin 75 MG Oral CapsuleSCD20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY20bfb8af-7933-4e5c-a2b5-010659d9125b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1172-1692381172011000 CAPSULE in 1 BOTTLE (69238-1172-1) 1000 capsule2017-06-280000-00-00NoNoCurrent
69238-1172-36923811720330 CAPSULE in 1 BOTTLE (69238-1172-3) 30 capsule2017-06-280000-00-00NoNoCurrent
69238-1172-96923811720990 CAPSULE in 1 BOTTLE (69238-1172-9) 90 capsule2017-06-280000-00-00NoNoCurrent