Doxepin Hydrochloride

Product NDC
72205-092
11-digit product format
722050092
Labeler code
72205
Product ID
72205-092_2b1f0144-65d8-451f-8054-6be1675f102c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA215113
Marketing category
ANDA
Marketing start
2022-06-27
Substance
DOXEPIN HYDROCHLORIDE
Active strength
100 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 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
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 · 145 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215113-001DOXEPIN 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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215113-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215113-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215113-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215113-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215113-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-06-242680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 145 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215113-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215113-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215113-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215113-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215113-005AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE100 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
2b1f0144-65d8-451f-8054-6be1675f102cAvailable 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
72205-092-91Doxepin Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1001
72205-092-99Doxepin Hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-092-91EA - Each72205-092ef117d44-b05d-4a3c-9591-fd103d5b68d512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-092DOXEPIN HYDROCHLORIDE CAPSULE [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20220629_2b1f0144-65d8-451f-8054-6be1675f102c.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 HYDROCHLORIDENovadoz Pharmaceuticals LLC2b1f0144-65d8-451f-8054-6be1675f102c2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
ndc (product): 72205-092
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 HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.5ee0f8e6-df05-4166-a614-77e124db95ae2025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.670edc2b-7914-479e-b4dd-d5c86706a6312025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.d29a8c70-cf1c-4bf8-bb87-1c80babce64e2025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.90d9041f-985b-470b-8cbb-f05dbfc770c92025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215113
application number: ANDA215113
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.99ff6e3e-8c12-4393-96ae-206d86d269472025-09-29Boxed 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
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
1000058doxepin HCl 100 MG Oral CapsulePSN99ff6e3e-8c12-4393-96ae-206d86d269472
1000058doxepin 100 MG Oral CapsuleSCD99ff6e3e-8c12-4393-96ae-206d86d269472
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY99ff6e3e-8c12-4393-96ae-206d86d269472
1000048doxepin HCl 10 MG Oral CapsulePSN2b1f0144-65d8-451f-8054-6be1675f102c1
1000058doxepin HCl 100 MG Oral CapsulePSN2b1f0144-65d8-451f-8054-6be1675f102c1
1000070doxepin HCl 25 MG Oral CapsulePSN2b1f0144-65d8-451f-8054-6be1675f102c1
1000076doxepin HCl 50 MG Oral CapsulePSN2b1f0144-65d8-451f-8054-6be1675f102c1
1000097doxepin HCl 75 MG Oral CapsulePSN2b1f0144-65d8-451f-8054-6be1675f102c1
1000048doxepin 10 MG Oral CapsuleSCD2b1f0144-65d8-451f-8054-6be1675f102c1
1000058doxepin 100 MG Oral CapsuleSCD2b1f0144-65d8-451f-8054-6be1675f102c1
1000070doxepin 25 MG Oral CapsuleSCD2b1f0144-65d8-451f-8054-6be1675f102c1
1000076doxepin 50 MG Oral CapsuleSCD2b1f0144-65d8-451f-8054-6be1675f102c1
1000097doxepin 75 MG Oral CapsuleSCD2b1f0144-65d8-451f-8054-6be1675f102c1
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY2b1f0144-65d8-451f-8054-6be1675f102c1
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY2b1f0144-65d8-451f-8054-6be1675f102c1
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY2b1f0144-65d8-451f-8054-6be1675f102c1
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY2b1f0144-65d8-451f-8054-6be1675f102c1
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY2b1f0144-65d8-451f-8054-6be1675f102c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-092-9172205009291100 CAPSULE in 1 BOTTLE, PLASTIC (72205-092-91) 100 capsule2022-06-270000-00-00NoNoCurrent
72205-092-99722050092991000 CAPSULE in 1 BOTTLE, PLASTIC (72205-092-99) 1000 capsule2022-06-270000-00-00NoNoCurrent