FDA.reportPublic FDA data

DOXEPIN HYDROCHLORIDE

Product NDC
46708-645
11-digit product format
467080645
Labeler code
46708
Product ID
46708-645_5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA215076
Marketing category
ANDA
Marketing start
2021-04-23
Substance
DOXEPIN HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000048, 1000058, 1000070, 1000076, 1000097

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
46708-645-31DOXEPIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1002
46708-645-91DOXEPIN HYDROCHLORIDE1000 in 1 BOTTLECAPSULE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-645DOXEPIN HYDROCHLORIDE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 2 package rows20230129_842b595b-dc54-4898-a178-1d2241cc065f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN842b595b-dc54-4898-a178-1d2241cc065f2
1000058doxepin HCl 100 MG Oral CapsulePSN842b595b-dc54-4898-a178-1d2241cc065f2
1000070doxepin HCl 25 MG Oral CapsulePSN842b595b-dc54-4898-a178-1d2241cc065f2
1000076doxepin HCl 50 MG Oral CapsulePSN842b595b-dc54-4898-a178-1d2241cc065f2
1000097doxepin HCl 75 MG Oral CapsulePSN842b595b-dc54-4898-a178-1d2241cc065f2
1000048doxepin 10 MG Oral CapsuleSCD842b595b-dc54-4898-a178-1d2241cc065f2
1000058doxepin 100 MG Oral CapsuleSCD842b595b-dc54-4898-a178-1d2241cc065f2
1000070doxepin 25 MG Oral CapsuleSCD842b595b-dc54-4898-a178-1d2241cc065f2
1000076doxepin 50 MG Oral CapsuleSCD842b595b-dc54-4898-a178-1d2241cc065f2
1000097doxepin 75 MG Oral CapsuleSCD842b595b-dc54-4898-a178-1d2241cc065f2
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY842b595b-dc54-4898-a178-1d2241cc065f2
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY842b595b-dc54-4898-a178-1d2241cc065f2
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY842b595b-dc54-4898-a178-1d2241cc065f2
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY842b595b-dc54-4898-a178-1d2241cc065f2
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY842b595b-dc54-4898-a178-1d2241cc065f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-645-3146708064531100 CAPSULE in 1 BOTTLE (46708-645-31) 100 capsule2021-04-230000-00-00NoNoCurrent
46708-645-91467080645911000 CAPSULE in 1 BOTTLE (46708-645-91) 1000 capsule2021-04-230000-00-00NoNoCurrent