Doxepin HCL

Product NDC
72189-633
11-digit product format
721890633
Labeler code
72189
Product ID
72189-633_3a870ceb-5a96-9351-e063-6294a90a3027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA215113
Marketing category
ANDA
Marketing start
2025-07-22
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 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 HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000048

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
72189-633-30Doxepin HCL30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-633-30EA - Each72189-6331d0eb732-4f06-4a19-b02a-4697f2defeb012025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN3a870ceb-5a95-9351-e063-6294a90a30271
1000048doxepin 10 MG Oral CapsuleSCD3a870ceb-5a95-9351-e063-6294a90a30271
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY3a870ceb-5a95-9351-e063-6294a90a30271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-633-307218906333030 CAPSULE in 1 BOTTLE (72189-633-30) 30 capsule2025-07-22NoNoHistorical