Doxepin Hydrochloride

Product NDC
48433-035
Requested package NDC
48433-035-20
11-digit product format
484330035
Labeler code
48433
Product ID
48433-035_4c4c90ec-fb2d-e45d-e063-6294a90a419a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Safecor Health, LLC
Application
ANDA070791
Marketing category
ANDA
Marketing start
2026-02-23
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 1.

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 5 · 180 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070791-001DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1986-05-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070791-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1986-05-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070791-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALABRS1986-05-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070791-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1986-05-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070791-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRS1986-05-131e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070791-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070791-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070791-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070791-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070791-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070791-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070791-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070791-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070791-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070791-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070791-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070791-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070791-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070791-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070791-005AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070791-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070791-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070791-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070791-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070791-005AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070791-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070791-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070791-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070791-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070791-005AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070791-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070791-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070791-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070791-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070791-005AB11e350fbaab3a…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 48433-035-20
ndc (product): 48433-035
ndc11 (package): 48433003520
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
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

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000048Internal RxNorm lookup
1000058Internal RxNorm lookup
1000070Internal RxNorm lookup
1000076Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2297f75-c498-419b-aa29-057271313a7fAvailable 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
48433-035-01Doxepin Hydrochloride1 in 1 BLISTER PACKCAPSULE12
48433-035-20Doxepin Hydrochloride100 in 1 CARTONCAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-035-20EA - Each48433-035bb390555-e646-4799-aab0-0b8a132346fd12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 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 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
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYa2297f75-c498-419b-aa29-057271313a7f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-035-2048433003520100 BLISTER PACK in 1 CARTON (48433-035-20) / 1 CAPSULE in 1 BLISTER PACK (48433-035-01) 100 blister pack2026-02-23NoNoCurrent