Home NDC 59746-704-05 Doxepin Hydrochloride
Product NDC 59746-704
Requested package NDC 59746-704-05
11-digit product format 597460704
Labeler code 59746
Product ID 59746-704_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 100 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215483-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2022-03-14 A215483-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2022-03-14 A215483-003 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-14 A215483-004 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-14 A215483-005 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2022-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A215483-001 DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2022-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A215483-002 DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2022-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A215483-003 DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2022-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A215483-004 DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2022-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A215483-005 DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2022-03-14 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-704 DOXEPIN HYDROCHLORIDE CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Legacy NDC 20220317_47bf6f58-627c-4955-a835-ce0556188906.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59746-704-05 59746070405 500 CAPSULE in 1 BOTTLE, PLASTIC (59746-704-05) 500 capsule 2021-12-01 0000-00-00 No No Current