Doxepin HCL

Product NDC
72189-388
11-digit product format
721890388
Labeler code
72189
Product ID
72189-388_eb643108-7ae3-f476-e053-2995a90ab148
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA215483
Marketing category
ANDA
Marketing start
2022-10-19
Marketing end
0000-00-00
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72189-388DDiscontinued by firm2026-10-05
excluded packagepackage72189-38872189-388-30DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-388-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-388-300efc9e666f02…f202fb6c5f17…

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
A215483-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14
A215483-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14
A215483-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14
A215483-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14
A215483-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215483-001AB
A215483-002AB
A215483-003AB
A215483-004AB
A215483-005AB

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 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-08-18 06:07:402026-07A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-1403ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215483-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215483-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A215483-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A215483-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A215483-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A215483-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215483-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215483-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-005AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-388-30EA - Each72189-3885de2f1f1-e67a-4552-97a7-8ca53194c99d12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-388DOXEPIN HCL CAPSULE [DIRECT_RX]3Legacy NDC20250123_eb643108-7ae2-f476-e053-2995a90ab148.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-388-307218903883030 CAPSULE in 1 BOTTLE (72189-388-30) 30 capsule2022-10-190000-00-00NoNoCurrent