Doxepin Hydrochloride

Product NDC
0378-3125
11-digit product format
003783125
Labeler code
0378
Product ID
0378-3125_335104fb-31eb-4460-b3ab-19869176b320
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA070791
Marketing category
ANDA
Marketing start
1986-05-13
Substance
DOXEPIN HYDROCHLORIDE
Active strength
25 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
A070791-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-13
A070791-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-13
A070791-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-13
A070791-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-13
A070791-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070791-001AB
A070791-002AB
A070791-003AB
A070791-004AB
A070791-005AB

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 06:07:402026-07A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-132680178bc6a6…

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 06:07:402026-07A070791-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070791-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070791-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070791-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070791-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070791-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070791-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070791-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070791-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070791-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070791-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070791-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070791-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070791-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070791-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070791-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070791-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070791-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070791-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070791-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070791-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070791-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070791-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070791-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070791-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070791-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070791-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070791-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070791-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070791-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070791-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070791-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070791-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070791-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070791-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070791-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070791-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070791-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070791-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070791-005AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE25 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
1533343b-f1ed-4c3a-bb36-23a748452b05Available 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
0378-3125-01Doxepin Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10018
0378-3125-10Doxepin Hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3125-01EA - Each0378-3125c6272711-5617-4de9-a190-d98605d0f01c12012-07-24
0378-3125-10EA - Each0378-3125da1156d4-64a4-4ed7-856d-7d67e00db12312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
SHELLACINACTIVE INGREDIENT46N107B71ODOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
SHELLACINACTIVE INGREDIENT46N107B71ODOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]11
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71ODOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ODOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
DOXEPIN HYDROCHLORIDEACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
DOXEPINACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71ODOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3125DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20240920_1533343b-f1ed-4c3a-bb36-23a748452b05.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackc577af7c-2405-4454-a169-5b6a4fa0c7bf2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070791
application number: ANDA070791
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDESafecor Health, LLCa2297f75-c498-419b-aa29-057271313a7f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070791
application number: ANDA070791
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1ede17e6-19e9-455c-ad16-8029a590735c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070791
application number: ANDA070791
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d2a91b99-513d-4894-ad6d-02d2028a22902026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070791
application number: ANDA070791
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.1533343b-f1ed-4c3a-bb36-23a748452b052025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070791
application number: ANDA070791
ndc (product): 0378-3125
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Institutional Inc.137a953b-3c48-405f-86a6-ff778cb7f5f22025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070791
application number: ANDA070791
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC10d9eba6-30d1-448a-8d92-a1a02df033032017-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070791
application number: ANDA070791

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSNc577af7c-2405-4454-a169-5b6a4fa0c7bf1015
1000070doxepin 25 MG Oral CapsuleSCDc577af7c-2405-4454-a169-5b6a4fa0c7bf1015
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYc577af7c-2405-4454-a169-5b6a4fa0c7bf1015
1000070doxepin HCl 25 MG Oral CapsulePSN1ede17e6-19e9-455c-ad16-8029a590735c24
1000070doxepin 25 MG Oral CapsuleSCD1ede17e6-19e9-455c-ad16-8029a590735c24
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY1ede17e6-19e9-455c-ad16-8029a590735c24
1000048doxepin HCl 10 MG Oral CapsulePSN1533343b-f1ed-4c3a-bb36-23a748452b0518
1000058doxepin HCl 100 MG Oral CapsulePSN1533343b-f1ed-4c3a-bb36-23a748452b0518
1000070doxepin HCl 25 MG Oral CapsulePSN1533343b-f1ed-4c3a-bb36-23a748452b0518
1000076doxepin HCl 50 MG Oral CapsulePSN1533343b-f1ed-4c3a-bb36-23a748452b0518
1000097doxepin HCl 75 MG Oral CapsulePSN1533343b-f1ed-4c3a-bb36-23a748452b0518
1000048doxepin 10 MG Oral CapsuleSCD1533343b-f1ed-4c3a-bb36-23a748452b0518
1000058doxepin 100 MG Oral CapsuleSCD1533343b-f1ed-4c3a-bb36-23a748452b0518
1000070doxepin 25 MG Oral CapsuleSCD1533343b-f1ed-4c3a-bb36-23a748452b0518
1000076doxepin 50 MG Oral CapsuleSCD1533343b-f1ed-4c3a-bb36-23a748452b0518
1000097doxepin 75 MG Oral CapsuleSCD1533343b-f1ed-4c3a-bb36-23a748452b0518
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY1533343b-f1ed-4c3a-bb36-23a748452b0518
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY1533343b-f1ed-4c3a-bb36-23a748452b0518
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY1533343b-f1ed-4c3a-bb36-23a748452b0518
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY1533343b-f1ed-4c3a-bb36-23a748452b0518
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY1533343b-f1ed-4c3a-bb36-23a748452b0518
1000048doxepin HCl 10 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000058doxepin HCl 100 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000070doxepin HCl 25 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000076doxepin HCl 50 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000048doxepin 10 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000058doxepin 100 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000070doxepin 25 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000076doxepin 50 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000048doxepin HCl 10 MG Oral CapsulePSNa2297f75-c498-419b-aa29-057271313a7f2
1000058doxepin HCl 100 MG Oral CapsulePSNa2297f75-c498-419b-aa29-057271313a7f2
1000070doxepin HCl 25 MG Oral CapsulePSNab4e12c5-461c-4fb3-857c-6b56547ae1022
1000070doxepin HCl 25 MG Oral CapsulePSNa2297f75-c498-419b-aa29-057271313a7f2
1000076doxepin HCl 50 MG Oral CapsulePSNa2297f75-c498-419b-aa29-057271313a7f2
1000048doxepin 10 MG Oral CapsuleSCDa2297f75-c498-419b-aa29-057271313a7f2
1000058doxepin 100 MG Oral CapsuleSCDa2297f75-c498-419b-aa29-057271313a7f2
1000070doxepin 25 MG Oral CapsuleSCDab4e12c5-461c-4fb3-857c-6b56547ae1022
1000070doxepin 25 MG Oral CapsuleSCDa2297f75-c498-419b-aa29-057271313a7f2
1000076doxepin 50 MG Oral CapsuleSCDa2297f75-c498-419b-aa29-057271313a7f2
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYa2297f75-c498-419b-aa29-057271313a7f2
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYa2297f75-c498-419b-aa29-057271313a7f2
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYa2297f75-c498-419b-aa29-057271313a7f2
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYab4e12c5-461c-4fb3-857c-6b56547ae1022
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYa2297f75-c498-419b-aa29-057271313a7f2
1000048doxepin HCl 10 MG Oral CapsulePSN10d9eba6-30d1-448a-8d92-a1a02df033031
1000070doxepin HCl 25 MG Oral CapsulePSN10d9eba6-30d1-448a-8d92-a1a02df033031
1000048doxepin 10 MG Oral CapsuleSCD10d9eba6-30d1-448a-8d92-a1a02df033031
1000070doxepin 25 MG Oral CapsuleSCD10d9eba6-30d1-448a-8d92-a1a02df033031
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY10d9eba6-30d1-448a-8d92-a1a02df033031
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY10d9eba6-30d1-448a-8d92-a1a02df033031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3125-0100378312501100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-01) 100 capsule1986-05-130000-00-00NoNoCurrent
0378-3125-10003783125101000 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-10) 1000 capsule1986-05-130000-00-00NoNoCurrent