FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
70756-428
11-digit product format
707560428
Labeler code
70756
Product ID
70756-428_56645f3c-452a-404f-ad51-2dab95f23e6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA215710
Marketing category
ANDA
Marketing start
2022-02-10
Substance
DOXEPIN HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 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
70756-428-11Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1008
70756-428-51Doxepin Hydrochloride500 in 1 BOTTLECAPSULE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-428-11EA - Each70756-4280ee24cf0-ef23-4297-9593-179df17221a612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-428DOXEPIN HYDROCHLORIDE CAPSULE [LIFESTAR PHARMA LLC]5Current NDC, Legacy NDC, 2 package rows20220215_fdaf3bd7-c456-40bd-8bc3-2b67eb1846c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000058doxepin HCl 100 MG Oral CapsulePSNfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000070doxepin HCl 25 MG Oral CapsulePSNfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000076doxepin HCl 50 MG Oral CapsulePSNfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000097doxepin HCl 75 MG Oral CapsulePSNfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000048doxepin 10 MG Oral CapsuleSCDfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000058doxepin 100 MG Oral CapsuleSCDfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000070doxepin 25 MG Oral CapsuleSCDfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000076doxepin 50 MG Oral CapsuleSCDfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000097doxepin 75 MG Oral CapsuleSCDfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSYfdaf3bd7-c456-40bd-8bc3-2b67eb1846c88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-428-1170756042811100 CAPSULE in 1 BOTTLE (70756-428-11) 100 capsule2022-02-100000-00-00NoNoCurrent
70756-428-5170756042851500 CAPSULE in 1 BOTTLE (70756-428-51) 500 capsule2022-02-100000-00-00NoNoCurrent