DOXEPIN HYDROCHLORIDE

Product NDC
46708-640
11-digit product format
467080640
Labeler code
46708
Product ID
46708-640_5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA215076
Marketing category
ANDA
Marketing start
2021-04-23
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
A215076-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-21
A215076-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-21
A215076-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-21
A215076-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-21
A215076-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215076-001AB
A215076-002AB
A215076-003AB
A215076-004AB
A215076-005AB

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 · 170 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215076-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07A215076-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07A215076-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07A215076-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07A215076-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215076-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215076-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215076-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215076-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215076-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215076-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215076-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215076-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215076-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215076-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215076-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215076-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215076-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215076-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215076-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215076-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215076-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215076-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215076-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215076-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215076-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215076-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215076-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215076-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215076-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215076-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215076-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215076-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215076-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215076-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215076-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215076-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215076-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215076-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215076-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-212680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 170 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215076-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215076-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215076-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215076-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215076-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215076-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215076-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215076-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215076-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215076-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215076-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215076-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215076-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215076-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215076-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215076-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215076-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215076-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215076-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215076-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215076-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215076-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215076-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215076-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215076-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215076-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215076-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215076-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215076-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215076-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215076-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215076-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215076-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215076-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215076-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215076-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215076-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215076-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215076-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215076-005AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
DOXEPIN HYDROCHLORIDE
Listing expiration
2026-12-31

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
842b595b-dc54-4898-a178-1d2241cc065fAvailable 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
46708-640-31DOXEPIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1002
46708-640-91DOXEPIN HYDROCHLORIDE1000 in 1 BOTTLECAPSULE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-640DOXEPIN HYDROCHLORIDE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 2 package rows20230129_842b595b-dc54-4898-a178-1d2241cc065f.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack09a70f17-f934-4b4b-9277-6351d906ab472025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.21dc77be-23af-4a1f-b189-dfee8ae2f8942025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAlembic Pharmaceuticals Inc.4920401a-cde5-404b-82aa-c3c0e89110652025-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack06e027bb-516d-4a1d-b5a0-a66c051eb3672025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack19c8ad61-4e4f-4c59-b196-34a4e470459f2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
Doxepin HCLDOXEPIN HCLDirect_rx21c64f9f-cee2-60b0-e063-6294a90ae97e2024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale214bae5d-36e2-47ae-e063-6294a90a7ddd2024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1cec730e-3218-ddf6-e063-6294a90a916e2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEA-S Medication Solutions890248d7-73b1-4ed3-b252-85775defdf342024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAlembic Pharmaceuticals Limited842b595b-dc54-4898-a178-1d2241cc065f2023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
ndc (product): 46708-640

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN842b595b-dc54-4898-a178-1d2241cc065f2
1000058doxepin HCl 100 MG Oral CapsulePSN842b595b-dc54-4898-a178-1d2241cc065f2
1000070doxepin HCl 25 MG Oral CapsulePSN842b595b-dc54-4898-a178-1d2241cc065f2
1000076doxepin HCl 50 MG Oral CapsulePSN842b595b-dc54-4898-a178-1d2241cc065f2
1000097doxepin HCl 75 MG Oral CapsulePSN842b595b-dc54-4898-a178-1d2241cc065f2
1000048doxepin 10 MG Oral CapsuleSCD842b595b-dc54-4898-a178-1d2241cc065f2
1000058doxepin 100 MG Oral CapsuleSCD842b595b-dc54-4898-a178-1d2241cc065f2
1000070doxepin 25 MG Oral CapsuleSCD842b595b-dc54-4898-a178-1d2241cc065f2
1000076doxepin 50 MG Oral CapsuleSCD842b595b-dc54-4898-a178-1d2241cc065f2
1000097doxepin 75 MG Oral CapsuleSCD842b595b-dc54-4898-a178-1d2241cc065f2
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY842b595b-dc54-4898-a178-1d2241cc065f2
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY842b595b-dc54-4898-a178-1d2241cc065f2
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY842b595b-dc54-4898-a178-1d2241cc065f2
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY842b595b-dc54-4898-a178-1d2241cc065f2
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY842b595b-dc54-4898-a178-1d2241cc065f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-640-3146708064031100 CAPSULE in 1 BOTTLE (46708-640-31) 100 capsule2021-04-230000-00-00NoNoCurrent
46708-640-91467080640911000 CAPSULE in 1 BOTTLE (46708-640-91) 1000 capsule2021-04-230000-00-00NoNoCurrent