FDA.reportPublic FDA data

doxepin

Product NDC
70771-1528
11-digit product format
707711528
Labeler code
70771
Product ID
70771-1528_2a2843b4-5867-4df6-af9a-dbe0264d6f1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA202761
Marketing category
ANDA
Marketing start
2024-06-30
Substance
DOXEPIN HYDROCHLORIDE
Active strength
3 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 HYDROCHLORIDE3 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
eda77195-5c17-5c7f-a6a7-8c80d2f8ae5fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1528-0doxepin1000 in 1 BOTTLETABLET10003
70771-1528-1doxepin100 in 1 BOTTLETABLET1003
70771-1528-3doxepin30 in 1 BOTTLETABLET303
70771-1528-4doxepin10 in 1 CARTONTABLET103
70771-1528-4doxepin10 in 1 BLISTER PACKTABLET103
70771-1528-5doxepin500 in 1 BOTTLETABLET5003
70771-1528-9doxepin90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1528DOXEPIN TABLET [ZYDUS LIFESCIENCES LIMITED]3Current NDC, 7 package rows20250110_1461ede6-24f0-42a1-b801-0cf4ef404985.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966787doxepin 3 MG Oral TabletPSN1461ede6-24f0-42a1-b801-0cf4ef4049853
966793doxepin 6 MG Oral TabletPSN1461ede6-24f0-42a1-b801-0cf4ef4049853
966787doxepin 3 MG Oral TabletSCD1461ede6-24f0-42a1-b801-0cf4ef4049853
966793doxepin 6 MG Oral TabletSCD1461ede6-24f0-42a1-b801-0cf4ef4049853
966787doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral TabletSY1461ede6-24f0-42a1-b801-0cf4ef4049853
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSY1461ede6-24f0-42a1-b801-0cf4ef4049853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1528-0707711528001000 TABLET in 1 BOTTLE (70771-1528-0) 1000 tablet2024-06-30NoNoCurrent
70771-1528-170771152801100 TABLET in 1 BOTTLE (70771-1528-1) 100 tablet2024-06-30NoNoCurrent
70771-1528-37077115280330 TABLET in 1 BOTTLE (70771-1528-3) 30 tablet2024-06-30NoNoCurrent
70771-1528-47077115280410 BLISTER PACK in 1 CARTON (70771-1528-4) / 10 TABLET in 1 BLISTER PACK10 blister pack2024-06-30NoNoCurrent
70771-1528-570771152805500 TABLET in 1 BOTTLE (70771-1528-5) 500 tablet2024-06-30NoNoCurrent
70771-1528-97077115280990 TABLET in 1 BOTTLE (70771-1528-9) 90 tablet2024-06-30NoNoCurrent