Doxepin Hydrochloride

Product NDC
71335-0780
Requested package NDC
71335-0780-1
11-digit product format
713350780
Labeler code
71335
Product ID
71335-0780_5ff16ea4-9866-4d88-9f17-9687c8d5b66b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207482
Marketing category
ANDA
Marketing start
2017-06-28
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-078071335-0780-1DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207482-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28
A207482-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28
A207482-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28
A207482-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28
A207482-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207482-001AB
A207482-002AB
A207482-003AB
A207482-004AB
A207482-005AB

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207482-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207482-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207482-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-005AB12680178bc6a6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutions78cf65ff-43f9-4f5e-95dd-864acc89c02a2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDERedpharm Drug37451a61-ccb1-57b3-e063-6294a90a25922025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMajor Pharmaceuticalsdf3b6be0-6a64-4174-b351-dab2061f290e2025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack3bc72772-22ae-4f29-97ff-4a552b4df6d02025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAmneal Pharmaceuticals NY LLC20bfb8af-7933-4e5c-a2b5-010659d9125b2024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0780-17133507800130 CAPSULE in 1 BOTTLE (71335-0780-1) 30 capsule2018-04-190000-00-00NoNoCurrent