Doxepin Hydrochloride

Product NDC
71335-1665
11-digit product format
713351665
Labeler code
71335
Product ID
71335-1665_900275d2-4cc9-4fcb-b01d-4034c2357a0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211603
Marketing category
ANDA
Marketing start
2019-03-27
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-1665DDiscontinued by firm2026-10-05
excluded packagepackage71335-166571335-1665-1DDiscontinued by firm2026-10-05
excluded packagepackage71335-166571335-1665-2DDiscontinued by firm2026-10-05

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1665-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1665-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1665-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1665-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1665-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1665-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1665-28af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1665-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1665-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1665-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1665-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1665-11332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211603-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-27
A211603-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-27
A211603-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-27
A211603-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-27
A211603-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211603-001AB
A211603-002AB
A211603-003AB
A211603-004AB
A211603-005AB

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211603-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211603-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A211603-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A211603-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A211603-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A211603-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211603-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211603-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-005AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1665DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]6Legacy NDC20241121_900275d2-4cc9-4fcb-b01d-4034c2357a0a.zip

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1496dfc1-de50-471c-be87-1f1e2b70ab5a2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAurobindo Pharma Limitedf3c242dd-426e-4c69-8f21-2645361d5f272025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2bf7d838-6274-4d8a-91cb-b27e1e81d2732025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9ee26b24-7121-3107-e053-2995a90ac61c2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LP6ce7fde2-2d47-4238-9beb-555d352f46572022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPe98f371e-f7fe-4c8f-9491-6eb4c53d43ad2021-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1665-17133516650130 CAPSULE in 1 BOTTLE (71335-1665-1) 30 capsule2020-07-130000-00-00NoNoCurrent
71335-1665-27133516650260 CAPSULE in 1 BOTTLE (71335-1665-2) 60 capsule2021-12-280000-00-00NoNoCurrent