NDC 70771-1528-09 - doxepin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70771-1528
Requested NDC
70771-1528-09
Package NDCs from labels
70771-1528-3, 70771-1528-9, 70771-1528-1, 70771-1528-5, 70771-1528-0, 70771-1528-4, 70771-1528-09
Manufacturer
Zydus Lifesciences Limited
Effective date
2025-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
doxepin - Zydus Lifesciences LimitedZydus Lifesciences Limited2025-01-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1528-0doxepin1000 in 1 BOTTLETABLET10003
70771-1528-1doxepin100 in 1 BOTTLETABLET1003
70771-1528-3doxepin30 in 1 BOTTLETABLET303
70771-1528-4doxepin10 in 1 CARTONTABLET103
70771-1528-4doxepin10 in 1 BLISTER PACKTABLET103
70771-1528-5doxepin500 in 1 BOTTLETABLET5003
70771-1528-9doxepin90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1528DOXEPIN TABLET [ZYDUS LIFESCIENCES LIMITED]3Current NDC, 7 package rows20250110_1461ede6-24f0-42a1-b801-0cf4ef404985.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 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxepinDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.2a9c2159-e89e-47e4-b91c-ac5560607a2d2026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 966793
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.21dc77be-23af-4a1f-b189-dfee8ae2f8942026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.7a8c56ab-5dd1-4e1a-b26a-3af45b961dd02026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 966793
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.670edc2b-7914-479e-b4dd-d5c86706a6312026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.d29a8c70-cf1c-4bf8-bb87-1c80babce64e2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.90d9041f-985b-470b-8cbb-f05dbfc770c92026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.5ee0f8e6-df05-4166-a614-77e124db95ae2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.99ff6e3e-8c12-4393-96ae-206d86d269472026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.0ae2e882-2570-404b-8529-0414eee5f95a2026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
doxepin hydrochlorideDOXEPIN HYDROCHLORIDEGolden State Medical Supply, Inc.57efdc34-d619-e413-e063-6394a90a0e042026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 966793
rxcui: 966787
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENovadoz Pharmaceuticals LLC2b1f0144-65d8-451f-8054-6be1675f102c2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDENovadoz Pharmaceuticals LLC96086fd8-8fa3-4a2b-ac12-fe1a3ad4f3842026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 966793
rxcui: 966787
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutions78cf65ff-43f9-4f5e-95dd-864acc89c02a2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPd7a6768a-927b-4f51-858d-1ddfa9d5c5d32026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.46be666a-fb9f-42a5-a55c-ea15fd5538c92026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.4ecd3b43-b5f1-4cf4-af36-eb214c1a3c602026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DoxepinDOXEPINAjanta Pharma USA Inc.b198ade7-fe78-437e-82b4-693dfe45ab512026-06-18Warnings, Adverse reactionsExact identifier
rxcui: 966793
rxcui: 966787
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDECoupler LLC54616c93-2325-4719-e063-6394a90a39102026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDECoupler LLC538643c0-b8d1-d71f-e063-6294a90a77342026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DOXEPINDOXEPINNorthStar Rx LLC77782f36-d120-4c3d-bebd-c8b0f4749d982026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 966793
rxcui: 966787
unii: 3U9A0FE9N5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.