Doxepin hydrochloride

Product NDC
70518-3594
11-digit product format
705183594
Labeler code
70518
Product ID
70518-3594_4f5c2409-3357-cee1-e063-6294a90ae4ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212624
Marketing category
ANDA
Marketing start
2022-12-13
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage70518-359470518-3594-0DDiscontinued 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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-359470518-3594-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A212624-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-09-13
A212624-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-09-13
A212624-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-09-13
A212624-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-09-13
A212624-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212624-001AB
A212624-002AB
A212624-003AB
A212624-004AB
A212624-005AB

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 · 200 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212624-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07A212624-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07A212624-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07A212624-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07A212624-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-09-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212624-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212624-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212624-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212624-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212624-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212624-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212624-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212624-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212624-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212624-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A212624-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212624-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212624-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212624-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212624-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212624-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212624-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212624-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212624-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212624-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212624-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212624-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212624-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212624-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212624-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-09-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212624-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212624-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212624-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212624-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212624-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-09-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212624-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212624-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212624-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212624-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212624-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-09-132680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212624-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212624-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212624-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212624-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212624-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212624-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212624-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212624-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212624-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212624-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212624-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212624-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212624-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212624-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212624-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212624-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212624-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212624-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212624-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212624-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212624-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212624-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212624-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212624-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212624-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212624-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212624-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212624-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212624-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212624-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212624-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212624-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212624-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212624-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212624-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212624-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212624-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212624-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212624-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212624-005AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxepin hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3U9A0FE9N5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000048Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ecd3b43-b5f1-4cf4-af36-eb214c1a3c60Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3594-0Doxepin hydrochloride30 in 1 BLISTER PACKCAPSULE305
70518-3594-1Doxepin hydrochloride30 in 1 BLISTER PACKCAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3594DOXEPIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]2Current NDC, Legacy NDC, 2 package rows20240116_4ecd3b43-b5f1-4cf4-af36-eb214c1a3c60.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.46be666a-fb9f-42a5-a55c-ea15fd5538c92026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.4ecd3b43-b5f1-4cf4-af36-eb214c1a3c602026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624
ndc (product): 70518-3594
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDECoupler LLC54616c93-2325-4719-e063-6394a90a39102026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDECoupler LLC538643c0-b8d1-d71f-e063-6294a90a77342026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEAjanta Pharma USA Inc.1513c98c-e7ef-4009-b932-6757048bb86a2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624
Doxepin HCLDOXEPIN HCLDirect_Rx0ead9074-3478-7c3d-e063-6394a90a9d272024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack2cacce3a-4986-44a8-b4aa-6edb076d87bf2023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack0cbf87df-c447-4225-81f5-92c4bc3ef81d2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LP7cfbb3d0-f19f-4977-ad0f-77676a8c6f832023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack41046d94-1443-4bbd-96d0-8463604ae4592023-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPacb696a8-a74c-4c5d-9ce3-88f67558c2f22022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212624
application number: ANDA212624

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN4ecd3b43-b5f1-4cf4-af36-eb214c1a3c605
1000048doxepin 10 MG Oral CapsuleSCD4ecd3b43-b5f1-4cf4-af36-eb214c1a3c605
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY4ecd3b43-b5f1-4cf4-af36-eb214c1a3c605

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3594-07051835940030 CAPSULE in 1 BLISTER PACK (70518-3594-0) 30 capsule2022-12-130000-00-00NoNoCurrent
70518-3594-17051835940130 CAPSULE in 1 BLISTER PACK (70518-3594-1) 30 capsule2025-02-07NoNoCurrent