Doxepin Hydrochloride

Product NDC
59746-704
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59746-704DDiscontinued by firm2026-10-15
excluded packagepackage59746-70459746-704-01DDiscontinued by firm2026-10-15
excluded packagepackage59746-70459746-704-05DDiscontinued by firm2026-10-15
excluded packagepackage59746-70459746-704-90DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-704-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-704-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-704-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-704-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-704-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-704-05f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215483-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14
A215483-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14
A215483-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14
A215483-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14
A215483-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A215483-001AB
A215483-002AB
A215483-003AB
A215483-004AB
A215483-005AB

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.

Product history page 1 of 5 · 165 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14c2088c7a36db…
2026-10-15 13:18:302026-09A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14c2088c7a36db…
2026-10-15 13:18:302026-09A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14c2088c7a36db…
2026-10-15 13:18:302026-09A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14c2088c7a36db…
2026-10-15 13:18:302026-09A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14c2088c7a36db…
2026-09-14 22:38:342026-08A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-08-18 06:07:402026-07A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 165 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215483-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215483-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215483-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215483-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215483-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215483-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215483-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215483-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215483-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215483-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215483-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215483-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215483-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215483-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215483-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215483-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215483-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215483-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215483-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215483-005AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215483-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215483-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215483-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215483-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215483-005AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215483-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215483-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215483-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215483-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215483-005AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215483-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215483-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215483-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215483-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215483-005AB11e350fbaab3a…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-704-01EA - Each59746-70435cd92d7-defb-4e9b-aed8-39eb00af933b12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-704DOXEPIN 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
59746-704-0159746070401100 CAPSULE in 1 BOTTLE, PLASTIC (59746-704-01) 100 capsule2021-12-010000-00-00NoNoCurrent
59746-704-0559746070405500 CAPSULE in 1 BOTTLE, PLASTIC (59746-704-05) 500 capsule2021-12-010000-00-00NoNoCurrent
59746-704-905974607049090 CAPSULE in 1 BOTTLE, PLASTIC (59746-704-90) 90 capsule2021-12-010000-00-00NoNoCurrent