Doxepin Hydrochloride

Product NDC
50090-8009
11-digit product format
500908009
Labeler code
50090
Product ID
50090-8009_a3080566-8f40-48f5-8c34-1e100ff194da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207482
Marketing category
ANDA
Marketing start
2017-06-28
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-2884e616aacf4f…
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…

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 22:38:342026-08A207482-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207482-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207482-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A207482-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A207482-005AB184e616aacf4f…
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…

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
2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000048Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
78cf65ff-43f9-4f5e-95dd-864acc89c02aAvailable on FDA.report

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 · 4 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
ndc (product): 50090-8009
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-8009-05009080090090 CAPSULE in 1 BOTTLE (50090-8009-0) 90 capsule2026-07-07NoNoCurrent