Doxepin Hydrochloride

Product NDC
59651-173
11-digit product format
596510173
Labeler code
59651
Product ID
59651-173_5b5efe70-cce2-4950-94f0-d3aa869e442e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA211603
Marketing category
ANDA
Marketing start
2019-03-27
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 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
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.

Additional Listing Data#

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

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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000048Internal RxNorm lookup
1000058Internal RxNorm lookup
1000070Internal RxNorm lookup
1000076Internal RxNorm lookup
1000097Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3c242dd-426e-4c69-8f21-2645361d5f27Available 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
59651-173-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-173-01EA - Each59651-173d627f3e6-6688-41aa-a1ef-1942a05f8c3612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-173DOXEPIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 1 package rows20241011_f3c242dd-426e-4c69-8f21-2645361d5f27.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
ndc (product): 59651-173
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN2bf7d838-6274-4d8a-91cb-b27e1e81d2739
1000048doxepin 10 MG Oral CapsuleSCD2bf7d838-6274-4d8a-91cb-b27e1e81d2739
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY2bf7d838-6274-4d8a-91cb-b27e1e81d2739
1000048doxepin HCl 10 MG Oral CapsulePSNf3c242dd-426e-4c69-8f21-2645361d5f275
1000058doxepin HCl 100 MG Oral CapsulePSNf3c242dd-426e-4c69-8f21-2645361d5f275
1000070doxepin HCl 25 MG Oral CapsulePSNf3c242dd-426e-4c69-8f21-2645361d5f275
1000076doxepin HCl 50 MG Oral CapsulePSNf3c242dd-426e-4c69-8f21-2645361d5f275
1000097doxepin HCl 75 MG Oral CapsulePSNf3c242dd-426e-4c69-8f21-2645361d5f275
1000048doxepin 10 MG Oral CapsuleSCDf3c242dd-426e-4c69-8f21-2645361d5f275
1000058doxepin 100 MG Oral CapsuleSCDf3c242dd-426e-4c69-8f21-2645361d5f275
1000070doxepin 25 MG Oral CapsuleSCDf3c242dd-426e-4c69-8f21-2645361d5f275
1000076doxepin 50 MG Oral CapsuleSCDf3c242dd-426e-4c69-8f21-2645361d5f275
1000097doxepin 75 MG Oral CapsuleSCDf3c242dd-426e-4c69-8f21-2645361d5f275
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYf3c242dd-426e-4c69-8f21-2645361d5f275
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYf3c242dd-426e-4c69-8f21-2645361d5f275
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYf3c242dd-426e-4c69-8f21-2645361d5f275
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYf3c242dd-426e-4c69-8f21-2645361d5f275
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSYf3c242dd-426e-4c69-8f21-2645361d5f275
1000048doxepin HCl 10 MG Oral CapsulePSN9ee26b24-7121-3107-e053-2995a90ac61c3
1000048doxepin 10 MG Oral CapsuleSCD9ee26b24-7121-3107-e053-2995a90ac61c3
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY9ee26b24-7121-3107-e053-2995a90ac61c3
1000048doxepin HCl 10 MG Oral CapsulePSNe98f371e-f7fe-4c8f-9491-6eb4c53d43ad1
1000048doxepin HCl 10 MG Oral CapsulePSNb59becdb-e73c-2d27-e053-2995a90aa9461
1000048doxepin 10 MG Oral CapsuleSCDb59becdb-e73c-2d27-e053-2995a90aa9461
1000048doxepin 10 MG Oral CapsuleSCDe98f371e-f7fe-4c8f-9491-6eb4c53d43ad1
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYe98f371e-f7fe-4c8f-9491-6eb4c53d43ad1
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYb59becdb-e73c-2d27-e053-2995a90aa9461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-173-0159651017301100 CAPSULE in 1 BOTTLE (59651-173-01) 100 capsule2019-03-270000-00-00NoNoCurrent