Doxepin Hydrochloride

Product NDC
72789-072
11-digit product format
727890072
Labeler code
72789
Product ID
72789-072_47a923cf-2731-8fc9-e063-6294a90afa38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA070791
Marketing category
ANDA
Marketing start
1986-05-13
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxepin Hydrochloride
Listing expiration
2027-12-31

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
72789-072-30Doxepin Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-072DOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 1 package rows20241003_d2a91b99-513d-4894-ad6d-02d2028a2290.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNd2a91b99-513d-4894-ad6d-02d2028a229021
1000048doxepin 10 MG Oral CapsuleSCDd2a91b99-513d-4894-ad6d-02d2028a229021
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYd2a91b99-513d-4894-ad6d-02d2028a229021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-072-307278900723030 CAPSULE in 1 BOTTLE, PLASTIC (72789-072-30) 30 capsule2020-04-010000-00-00NoNoCurrent