FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
42806-529
11-digit product format
428060529
Labeler code
42806
Product ID
42806-529_a5adf083-8dd9-4482-a3f1-589ade22b653
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA210675
Marketing category
ANDA
Marketing start
2017-06-06
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 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 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
A210675-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2020-10-16
A210675-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2020-10-16
A210675-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2020-10-16
A210675-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-03
A210675-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210675-001AB
A210675-002AB
A210675-003AB
A210675-004AB
A210675-005AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210675-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2020-10-16a50c72e98297…
2026-08-01 22:54:322026-06A210675-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2020-10-16a50c72e98297…
2026-08-01 22:54:322026-06A210675-003DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2020-10-16a50c72e98297…
2026-08-01 22:54:322026-06A210675-004DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-03a50c72e98297…
2026-08-01 22:54:322026-06A210675-005DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210675-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A210675-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A210675-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A210675-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A210675-005AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEEpic Pharma, LLC5f0f6fee-2497-4915-b58b-bf369efcfd792024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210675
application number: ANDA210675
ndc (product): 42806-529
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS14002bad-2577-436d-91ca-ec1b80ab0c972023-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210675
application number: ANDA210675

Additional Listing Data#

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

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 · 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
5f0f6fee-2497-4915-b58b-bf369efcfd79Available 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
42806-529-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1005
42806-529-10Doxepin Hydrochloride1000 in 1 BOTTLECAPSULE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-529-01EA - Each42806-5293c2befa2-b970-4d25-8d72-0d2321c7738512022-01-06
42806-529-10EA - Each42806-5290f797bcc-8c5d-47ba-b560-0d378f907dea12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-529DOXEPIN HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]4Current NDC, Legacy NDC, 2 package rows20221230_5f0f6fee-2497-4915-b58b-bf369efcfd79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN5f0f6fee-2497-4915-b58b-bf369efcfd795
1000058doxepin HCl 100 MG Oral CapsulePSN5f0f6fee-2497-4915-b58b-bf369efcfd795
1000070doxepin HCl 25 MG Oral CapsulePSN5f0f6fee-2497-4915-b58b-bf369efcfd795
1000076doxepin HCl 50 MG Oral CapsulePSN5f0f6fee-2497-4915-b58b-bf369efcfd795
1000097doxepin HCl 75 MG Oral CapsulePSN5f0f6fee-2497-4915-b58b-bf369efcfd795
1000048doxepin 10 MG Oral CapsuleSCD5f0f6fee-2497-4915-b58b-bf369efcfd795
1000058doxepin 100 MG Oral CapsuleSCD5f0f6fee-2497-4915-b58b-bf369efcfd795
1000070doxepin 25 MG Oral CapsuleSCD5f0f6fee-2497-4915-b58b-bf369efcfd795
1000076doxepin 50 MG Oral CapsuleSCD5f0f6fee-2497-4915-b58b-bf369efcfd795
1000097doxepin 75 MG Oral CapsuleSCD5f0f6fee-2497-4915-b58b-bf369efcfd795
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY5f0f6fee-2497-4915-b58b-bf369efcfd795
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY5f0f6fee-2497-4915-b58b-bf369efcfd795
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY5f0f6fee-2497-4915-b58b-bf369efcfd795
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY5f0f6fee-2497-4915-b58b-bf369efcfd795
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY5f0f6fee-2497-4915-b58b-bf369efcfd795

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-529-0142806052901100 CAPSULE in 1 BOTTLE (42806-529-01) 100 capsule2017-06-060000-00-00NoNoCurrent
42806-529-10428060529101000 CAPSULE in 1 BOTTLE (42806-529-10) 1000 capsule2017-06-060000-00-00NoNoCurrent