Doxepin Hydrochloride

Product NDC
71335-2418
11-digit product format
713352418
Labeler code
71335
Product ID
71335-2418_8885944d-8f69-4cc1-b92c-fa15777dcc43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215113
Marketing category
ANDA
Marketing start
2022-06-27
Substance
DOXEPIN HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A215113-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-06-24
A215113-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-06-24
A215113-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-06-24
A215113-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-06-24
A215113-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215113-001AB
A215113-002AB
A215113-003AB
A215113-004AB
A215113-005AB

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 4 · 150 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215113-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-06-2484e616aacf4f…
2026-09-14 22:38:342026-08A215113-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-06-2484e616aacf4f…
2026-09-14 22:38:342026-08A215113-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-06-2484e616aacf4f…
2026-09-14 22:38:342026-08A215113-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-06-2484e616aacf4f…
2026-09-14 22:38:342026-08A215113-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-06-2484e616aacf4f…
2026-08-18 06:07:402026-07A215113-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A215113-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A215113-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A215113-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A215113-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215113-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215113-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215113-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215113-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215113-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215113-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215113-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215113-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215113-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215113-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A215113-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215113-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215113-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215113-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215113-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215113-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215113-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215113-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215113-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215113-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215113-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215113-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215113-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215113-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215113-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215113-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215113-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215113-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215113-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215113-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-06-2403ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215113-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215113-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A215113-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A215113-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A215113-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A215113-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215113-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215113-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215113-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215113-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215113-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215113-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215113-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215113-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215113-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215113-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215113-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215113-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215113-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215113-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215113-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215113-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215113-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215113-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215113-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215113-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215113-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215113-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215113-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215113-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215113-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215113-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215113-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215113-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215113-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215113-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215113-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215113-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215113-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215113-005AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Doxepin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE25 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
1000070Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
13da67ec-370c-4647-8440-80fd55f1398eAvailable 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
71335-2418-1Doxepin Hydrochloride30 in 1 BOTTLECAPSULE30100
71335-2418-2Doxepin Hydrochloride60 in 1 BOTTLECAPSULE60100
71335-2418-3Doxepin Hydrochloride28 in 1 BOTTLECAPSULE28100
71335-2418-4Doxepin Hydrochloride18 in 1 BOTTLECAPSULE18100
71335-2418-5Doxepin Hydrochloride90 in 1 BOTTLECAPSULE90100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2418DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20241114_13da67ec-370c-4647-8440-80fd55f1398e.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.670edc2b-7914-479e-b4dd-d5c86706a6312026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.d29a8c70-cf1c-4bf8-bb87-1c80babce64e2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.90d9041f-985b-470b-8cbb-f05dbfc770c92026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.5ee0f8e6-df05-4166-a614-77e124db95ae2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.99ff6e3e-8c12-4393-96ae-206d86d269472026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENovadoz Pharmaceuticals LLC2b1f0144-65d8-451f-8054-6be1675f102c2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPd7a6768a-927b-4f51-858d-1ddfa9d5c5d32026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutionse0460c02-3dae-4b19-845c-2ffcfb587f6d2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack94ee3c14-0ccc-4329-b012-63679a699a672025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HCLDOXEPIN HCLDirect_Rx3a870ceb-5a95-9351-e063-6294a90a30272025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack13da67ec-370c-4647-8440-80fd55f1398e2024-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
ndc (product): 71335-2418
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackefcae0f7-3491-470f-beea-1aff221782432024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSN13da67ec-370c-4647-8440-80fd55f1398e100
1000070doxepin 25 MG Oral CapsuleSCD13da67ec-370c-4647-8440-80fd55f1398e100
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY13da67ec-370c-4647-8440-80fd55f1398e100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2418-17133524180130 CAPSULE in 1 BOTTLE (71335-2418-1) 30 capsule2024-11-12NoNoCurrent
71335-2418-27133524180260 CAPSULE in 1 BOTTLE (71335-2418-2) 60 capsule2024-11-12NoNoCurrent
71335-2418-37133524180328 CAPSULE in 1 BOTTLE (71335-2418-3) 28 capsule2024-11-12NoNoCurrent
71335-2418-47133524180418 CAPSULE in 1 BOTTLE (71335-2418-4) 18 capsule2024-11-12NoNoCurrent
71335-2418-57133524180590 CAPSULE in 1 BOTTLE (71335-2418-5) 90 capsule2024-11-12NoNoCurrent