Doxepin hydrochloride

Product NDC
51407-812
11-digit product format
514070812
Labeler code
51407
Product ID
51407-812_2a07fb40-8690-5729-e063-6294a90a4078
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA214823
Marketing category
ANDA
Marketing start
2023-04-05
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 hydrochloride
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
51407-812-30Doxepin hydrochloride30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-812-30EA - Each51407-8127b1fdca0-f5a6-4187-bdef-2d86cffdcf4612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-812DOXEPIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, 1 package rows20250101_00ef7d0b-4bb9-cd5b-e063-6294a90abc35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966787doxepin 3 MG Oral TabletPSN00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966793doxepin 6 MG Oral TabletPSN00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966787doxepin 3 MG Oral TabletSCD00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966793doxepin 6 MG Oral TabletSCD00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966787doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral TabletSY00ef7d0b-4bb9-cd5b-e063-6294a90abc353
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSY00ef7d0b-4bb9-cd5b-e063-6294a90abc353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-812-305140708123030 TABLET in 1 BOTTLE (51407-812-30) 30 tablet2023-05-31NoNoHistorical