Doxepin Hydrochloride

Product NDC
69238-1172
11-digit product format
692381172
Labeler code
69238
Product ID
69238-1172_0d905a6d-9f40-435d-a39a-f97ce7264b15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA207482
Marketing category
ANDA
Marketing start
2017-06-28
Substance
DOXEPIN HYDROCHLORIDE
Active strength
75 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
A207482-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28
A207482-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28
A207482-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28
A207482-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28
A207482-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207482-001AB
A207482-002AB
A207482-003AB
A207482-004AB
A207482-005AB

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207482-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207482-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207482-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-005AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE75 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
20bfb8af-7933-4e5c-a2b5-010659d9125bAvailable 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
69238-1172-1Doxepin Hydrochloride1000 in 1 BOTTLECAPSULE100015
69238-1172-3Doxepin Hydrochloride30 in 1 BOTTLECAPSULE3015
69238-1172-9Doxepin Hydrochloride90 in 1 BOTTLECAPSULE9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1172-1EA - Each69238-1172bf7ddb89-a103-4c88-83c0-966d3a3393cf12017-08-11
69238-1172-9EA - Each69238-1172a470e7a3-6420-4ea8-9124-89fde35ad6a412017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1172DOXEPIN HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]15Current NDC, Legacy NDC, 3 package rows20241210_20bfb8af-7933-4e5c-a2b5-010659d9125b.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutions78cf65ff-43f9-4f5e-95dd-864acc89c02a2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDERedpharm Drug37451a61-ccb1-57b3-e063-6294a90a25922025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMajor Pharmaceuticalsdf3b6be0-6a64-4174-b351-dab2061f290e2025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack3bc72772-22ae-4f29-97ff-4a552b4df6d02025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAmneal Pharmaceuticals NY LLC20bfb8af-7933-4e5c-a2b5-010659d9125b2024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
ndc (product): 69238-1172

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000058doxepin HCl 100 MG Oral CapsulePSN20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000070doxepin HCl 25 MG Oral CapsulePSN20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000076doxepin HCl 50 MG Oral CapsulePSN20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000097doxepin HCl 75 MG Oral CapsulePSN20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000048doxepin 10 MG Oral CapsuleSCD20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000058doxepin 100 MG Oral CapsuleSCD20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000070doxepin 25 MG Oral CapsuleSCD20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000076doxepin 50 MG Oral CapsuleSCD20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000097doxepin 75 MG Oral CapsuleSCD20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY20bfb8af-7933-4e5c-a2b5-010659d9125b15
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY20bfb8af-7933-4e5c-a2b5-010659d9125b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1172-1692381172011000 CAPSULE in 1 BOTTLE (69238-1172-1) 1000 capsule2017-06-280000-00-00NoNoCurrent
69238-1172-36923811720330 CAPSULE in 1 BOTTLE (69238-1172-3) 30 capsule2017-06-280000-00-00NoNoCurrent
69238-1172-96923811720990 CAPSULE in 1 BOTTLE (69238-1172-9) 90 capsule2017-06-280000-00-00NoNoCurrent