Doxepin Hydrochloride

Product NDC
55700-982
11-digit product format
557000982
Labeler code
55700
Product ID
55700-982_bd859d0e-6f92-40fa-82ad-96cf6f2b5a3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA215483
Marketing category
ANDA
Marketing start
2022-08-23
Marketing end
0000-00-00
Substance
DOXEPIN HYDROCHLORIDE
Active strength
50 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 productproduct55700-982DDiscontinued by firm2026-10-05
excluded packagepackage55700-98255700-982-30DDiscontinued 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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-982-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-982-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-982-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-982-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-982-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-982-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-982-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-982-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-982-30DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-982-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-982-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-982-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55700-982-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55700-982-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-982-30IInactivated by FDA1332a3947898…d4bfe170f9cd…

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-982-302025-01-08C16284748780-11030e365-52c1-111a-e063-dadaa90a10e2Doxepin Hydrochloride capsules
55700-982-302024-01-30C16284748780-11030e365-52c1-111a-e063-dadaa90a10e2Doxepin Hydrochloride capsules

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-982-30EA - Each55700-982d560d1d2-f643-47f4-a456-3f8537ce5d1a12022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-982-305570009823030 CAPSULE in 1 BOTTLE, PLASTIC (55700-982-30) 30 capsule2022-08-230000-00-00NoNoCurrent