FDA.reportPublic FDA data

DOXEPIN HYDROCHLORIDE

Product NDC
62332-639
11-digit product format
623320639
Labeler code
62332
Product ID
62332-639_c3977b05-a9fc-4cc4-adfc-731abe6613dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215076
Marketing category
ANDA
Marketing start
2021-04-23
Substance
DOXEPIN HYDROCHLORIDE
Active strength
75 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
A215076-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-21
A215076-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-21
A215076-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-21
A215076-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-21
A215076-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215076-001AB
A215076-002AB
A215076-003AB
A215076-004AB
A215076-005AB

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 22:54:322026-06A215076-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-04-21a50c72e98297…
2026-08-01 22:54:322026-06A215076-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-04-21a50c72e98297…
2026-08-01 22:54:322026-06A215076-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2021-04-21a50c72e98297…
2026-08-01 22:54:322026-06A215076-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2021-04-21a50c72e98297…
2026-08-01 22:54:322026-06A215076-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-04-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215076-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A215076-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A215076-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A215076-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A215076-005AB1a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack09a70f17-f934-4b4b-9277-6351d906ab472025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.21dc77be-23af-4a1f-b189-dfee8ae2f8942025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAlembic Pharmaceuticals Inc.4920401a-cde5-404b-82aa-c3c0e89110652025-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
ndc (product): 62332-639
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack06e027bb-516d-4a1d-b5a0-a66c051eb3672025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack19c8ad61-4e4f-4c59-b196-34a4e470459f2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
Doxepin HCLDOXEPIN HCLDirect_rx21c64f9f-cee2-60b0-e063-6294a90ae97e2024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale214bae5d-36e2-47ae-e063-6294a90a7ddd2024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1cec730e-3218-ddf6-e063-6294a90a916e2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEA-S Medication Solutions890248d7-73b1-4ed3-b252-85775defdf342024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAlembic Pharmaceuticals Limited842b595b-dc54-4898-a178-1d2241cc065f2023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215076
application number: ANDA215076

Additional Listing Data#

Finished product
Yes
Brand name base
DOXEPIN HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE75 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
4920401a-cde5-404b-82aa-c3c0e8911065Available 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
62332-639-31DOXEPIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1007
62332-639-91DOXEPIN HYDROCHLORIDE1000 in 1 BOTTLECAPSULE10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-639-31EA - Each62332-639fb842a4f-3ea3-4ea1-9d2d-95cecd37496d12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-639DOXEPIN HYDROCHLORIDE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20211014_4920401a-cde5-404b-82aa-c3c0e8911065.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN4920401a-cde5-404b-82aa-c3c0e89110657
1000058doxepin HCl 100 MG Oral CapsulePSN4920401a-cde5-404b-82aa-c3c0e89110657
1000070doxepin HCl 25 MG Oral CapsulePSN4920401a-cde5-404b-82aa-c3c0e89110657
1000076doxepin HCl 50 MG Oral CapsulePSN4920401a-cde5-404b-82aa-c3c0e89110657
1000097doxepin HCl 75 MG Oral CapsulePSN4920401a-cde5-404b-82aa-c3c0e89110657
1000048doxepin 10 MG Oral CapsuleSCD4920401a-cde5-404b-82aa-c3c0e89110657
1000058doxepin 100 MG Oral CapsuleSCD4920401a-cde5-404b-82aa-c3c0e89110657
1000070doxepin 25 MG Oral CapsuleSCD4920401a-cde5-404b-82aa-c3c0e89110657
1000076doxepin 50 MG Oral CapsuleSCD4920401a-cde5-404b-82aa-c3c0e89110657
1000097doxepin 75 MG Oral CapsuleSCD4920401a-cde5-404b-82aa-c3c0e89110657
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY4920401a-cde5-404b-82aa-c3c0e89110657
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY4920401a-cde5-404b-82aa-c3c0e89110657
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY4920401a-cde5-404b-82aa-c3c0e89110657
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY4920401a-cde5-404b-82aa-c3c0e89110657
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY4920401a-cde5-404b-82aa-c3c0e89110657

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-639-3162332063931100 CAPSULE in 1 BOTTLE (62332-639-31) 100 capsule2021-04-230000-00-00NoNoCurrent
62332-639-91623320639911000 CAPSULE in 1 BOTTLE (62332-639-91) 1000 capsule2021-04-230000-00-00NoNoCurrent