FDA.reportPublic FDA data

Doxepin

Product NDC
64380-204
11-digit product format
643800204
Labeler code
64380
Product ID
64380-204_b6b0f575-6e3a-4011-b33f-a051103058c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA202510
Marketing category
ANDA
Marketing start
2022-09-12
Substance
DOXEPIN HYDROCHLORIDE
Active strength
6 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui966787, 966793

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
64380-204-01Doxepin30 in 1 BOTTLE, PLASTICTABLET306
64380-204-02Doxepin100 in 1 BOTTLE, PLASTICTABLET1006
64380-204-03Doxepin500 in 1 BOTTLE, PLASTICTABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-204-01EA - Each64380-2041307fa0e-8c2d-4e4f-a9db-cd8e2b8112a812022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-204DOXEPIN (DOXEPIN HYDROCHLORIDE) TABLET [STRIDES PHARMA SCIENCE LIMITED]6Current NDC, Legacy NDC, 3 package rows20250323_399866d5-3fa6-46d0-9c62-492d5997bc4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966793doxepin 6 MG Oral TabletPSN207bb11e-6029-4506-92d2-2d8a776b9408101
966793doxepin 6 MG Oral TabletSCD207bb11e-6029-4506-92d2-2d8a776b9408101
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSY207bb11e-6029-4506-92d2-2d8a776b9408101
966787doxepin 3 MG Oral TabletPSN399866d5-3fa6-46d0-9c62-492d5997bc4f6
966793doxepin 6 MG Oral TabletPSN399866d5-3fa6-46d0-9c62-492d5997bc4f6
966787doxepin 3 MG Oral TabletSCD399866d5-3fa6-46d0-9c62-492d5997bc4f6
966793doxepin 6 MG Oral TabletSCD399866d5-3fa6-46d0-9c62-492d5997bc4f6
966787doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral TabletSY399866d5-3fa6-46d0-9c62-492d5997bc4f6
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSY399866d5-3fa6-46d0-9c62-492d5997bc4f6
966793doxepin 6 MG Oral TabletPSN2a9c2159-e89e-47e4-b91c-ac5560607a2d1
966793doxepin 6 MG Oral TabletSCD2a9c2159-e89e-47e4-b91c-ac5560607a2d1
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSY2a9c2159-e89e-47e4-b91c-ac5560607a2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-204-016438002040130 TABLET in 1 BOTTLE, PLASTIC (64380-204-01) 30 tablet2022-09-120000-00-00NoNoCurrent
64380-204-0264380020402100 TABLET in 1 BOTTLE, PLASTIC (64380-204-02) 100 tablet2022-09-120000-00-00NoNoCurrent
64380-204-0364380020403500 TABLET in 1 BOTTLE, PLASTIC (64380-204-03) 500 tablet2022-09-120000-00-00NoNoCurrent