DOXEPIN

Product NDC
59651-845
11-digit product format
596510845
Labeler code
59651
Product ID
59651-845_29b3bf98-2c57-4d87-b5eb-5232e46dc639
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216041
Marketing category
ANDA
Marketing start
2025-07-12
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
59651-845-30DOXEPIN30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-845-30EA - Each59651-84578d3f6a6-ebd2-49c2-8c22-d28c8a1034b912025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966787doxepin 3 MG Oral TabletPSN29b3bf98-2c57-4d87-b5eb-5232e46dc6391
966793doxepin 6 MG Oral TabletPSN29b3bf98-2c57-4d87-b5eb-5232e46dc6391
966787doxepin 3 MG Oral TabletSCD29b3bf98-2c57-4d87-b5eb-5232e46dc6391
966793doxepin 6 MG Oral TabletSCD29b3bf98-2c57-4d87-b5eb-5232e46dc6391
966787doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral TabletSY29b3bf98-2c57-4d87-b5eb-5232e46dc6391
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSY29b3bf98-2c57-4d87-b5eb-5232e46dc6391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-845-305965108453030 TABLET in 1 BOTTLE (59651-845-30) 30 tablet2025-07-12NoNoCurrent