FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
71205-534
11-digit product format
712050534
Labeler code
71205
Product ID
71205-534_e98f371e-f7fe-4c8f-9491-6eb4c53d43ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211603
Marketing category
ANDA
Marketing start
2019-03-27
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 Hydrochloride
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
71205-534-30Doxepin Hydrochloride30 in 1 BOTTLECAPSULE301
71205-534-60Doxepin Hydrochloride60 in 1 BOTTLECAPSULE601
71205-534-90Doxepin Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-534-30EA - Each71205-534a67360b4-3aec-4bdb-b4f8-c0f0f6a544bf12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-534DOXEPIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20210220_e98f371e-f7fe-4c8f-9491-6eb4c53d43ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNe98f371e-f7fe-4c8f-9491-6eb4c53d43ad1
1000048doxepin 10 MG Oral CapsuleSCDe98f371e-f7fe-4c8f-9491-6eb4c53d43ad1
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYe98f371e-f7fe-4c8f-9491-6eb4c53d43ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-534-307120505343030 CAPSULE in 1 BOTTLE (71205-534-30) 30 capsule2021-02-160000-00-00NoNoCurrent
71205-534-607120505346060 CAPSULE in 1 BOTTLE (71205-534-60) 60 capsule2021-02-160000-00-00NoNoCurrent
71205-534-907120505349090 CAPSULE in 1 BOTTLE (71205-534-90) 90 capsule2021-02-160000-00-00NoNoCurrent