FDA.reportPublic FDA data

NDC 70771-1529-01 - 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
70771-1529
Requested NDC
70771-1529-01
Package NDCs from labels
70771-1529-3, 70771-1529-9, 70771-1529-1, 70771-1529-5, 70771-1529-0, 70771-1529-4, 70771-1529-01
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
70771-1529-0doxepin1000 in 1 BOTTLETABLET10003
70771-1529-1doxepin100 in 1 BOTTLETABLET1003
70771-1529-3doxepin30 in 1 BOTTLETABLET303
70771-1529-4doxepin10 in 1 CARTONTABLET103
70771-1529-4doxepin10 in 1 BLISTER PACKTABLET103
70771-1529-5doxepin500 in 1 BOTTLETABLET5003
70771-1529-9doxepin90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1529DOXEPIN 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 2 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
SilenorDOXEPIN HYDROCHLORIDECurrax Pharmaceuticals LLC1bec1223-5239-4eb6-a9e8-62444106d2c02026-04-21Warnings, Adverse reactionsExact identifier
rxcui: 966793
rxcui: 966787
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackc577af7c-2405-4454-a169-5b6a4fa0c7bf2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDESafecor Health, LLCa2297f75-c498-419b-aa29-057271313a7f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1ede17e6-19e9-455c-ad16-8029a590735c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d2a91b99-513d-4894-ad6d-02d2028a22902026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DoxepinDOXEPINNorth Star Rx LLC12edd5c6-c863-b83a-e063-6294a90a2f362025-12-30Warnings, Adverse reactionsExact identifier
rxcui: 966793
rxcui: 966787
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDELeading Pharma, LLCe6a4cb10-1928-4abe-8797-404c9ddc37dd2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDELeading Pharma, LLCd5df4beb-8048-4b83-aa59-19876437001d2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1496dfc1-de50-471c-be87-1f1e2b70ab5a2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutionse0460c02-3dae-4b19-845c-2ffcfb587f6d2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDERedpharm Drug37451a61-ccb1-57b3-e063-6294a90a25922025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEChartwell RX, LLC33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEAjanta Pharma USA Inc.1513c98c-e7ef-4009-b932-6757048bb86a2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8f7e9677-cc84-414b-8eb8-33993d285bb32025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DoxepinDOXEPINMarlex Pharmaceuticals, Inc.06e79a65-1455-804e-e063-6394a90a2f3d2025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 966793
rxcui: 966787
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack09a70f17-f934-4b4b-9277-6351d906ab472025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5

Reported adverse events (FAERS/openFDA)#

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