FDA.reportPublic FDA data

Doxepin hydrochloride

Product NDC
71205-695
11-digit product format
712050695
Labeler code
71205
Product ID
71205-695_acb696a8-a74c-4c5d-9ce3-88f67558c2f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA212624
Marketing category
ANDA
Marketing start
2019-12-20
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
71205-695-30Doxepin hydrochloride30 in 1 BOTTLECAPSULE301
71205-695-60Doxepin hydrochloride60 in 1 BOTTLECAPSULE601
71205-695-90Doxepin hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-695-30EA - Each71205-695996c2e3b-5a53-4ef2-bc50-0a817b6479e812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-695DOXEPIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20220915_acb696a8-a74c-4c5d-9ce3-88f67558c2f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNacb696a8-a74c-4c5d-9ce3-88f67558c2f21
1000048doxepin 10 MG Oral CapsuleSCDacb696a8-a74c-4c5d-9ce3-88f67558c2f21
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYacb696a8-a74c-4c5d-9ce3-88f67558c2f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-695-307120506953030 CAPSULE in 1 BOTTLE (71205-695-30) 30 capsule2022-09-120000-00-00NoNoCurrent
71205-695-607120506956060 CAPSULE in 1 BOTTLE (71205-695-60) 60 capsule2022-09-120000-00-00NoNoCurrent
71205-695-907120506959090 CAPSULE in 1 BOTTLE (71205-695-90) 90 capsule2022-09-120000-00-00NoNoCurrent