Doxepin Hydrochloride

Product NDC
59746-701
11-digit product format
597460701
Labeler code
59746
Product ID
59746-701_71faef93-5aa0-4d3b-a039-adf3bc8967c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
JUBILANT CADISTA PHARMACEUTICALS INC.
Application
ANDA215483
Marketing category
ANDA
Marketing start
2021-12-01
Marketing end
0000-00-00
Substance
DOXEPIN HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-701-01EA - Each59746-70180b4a372-e3b3-42fa-a5ec-88886b5889b912022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-701DOXEPIN HYDROCHLORIDE CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]4Legacy NDC20220317_47bf6f58-627c-4955-a835-ce0556188906.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-701-0159746070101100 CAPSULE in 1 BOTTLE, PLASTIC (59746-701-01) 100 capsule2021-12-010000-00-00NoNoCurrent
59746-701-0559746070105500 CAPSULE in 1 BOTTLE, PLASTIC (59746-701-05) 500 capsule2021-12-010000-00-00NoNoCurrent
59746-701-905974607019090 CAPSULE in 1 BOTTLE, PLASTIC (59746-701-90) 90 capsule2021-12-010000-00-00NoNoCurrent