FDA.reportPublic FDA data

NDC 70121-1218-01 - Doxorubicin Hydrochloride

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
70121-1218
Requested NDC
70121-1218-01
Package NDCs from labels
70121-1218-1, 70121-1218-7, 70121-1218-01
Manufacturer
Amneal Pharmaceuticals LLC
Effective date
2024-05-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Doxorubicin Hydrochloride - Amneal Pharmaceuticals LLCAmneal Pharmaceuticals LLC2024-05-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1218-1Doxorubicin Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,112
70121-1218-1Doxorubicin Hydrochloride10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1012
70121-1218-7Doxorubicin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1218DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]12Current NDC, Legacy NDC, 3 package rows20240830_d928625e-c1ef-4f25-8d25-764c8c6aab67.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDEBluePoint Laboratories55889588-c5f1-d9bc-e063-6294a90a57912026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEBluePoint Laboratoriesf6508535-e7a7-4e50-8d0c-43deda8d0d082026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Inc1fd148fb-0fbc-4b6f-b790-23546fb46a712026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Inc00634b2b-4e48-4178-8877-28582af894ad2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDENorthStar RxLLCddf55319-bf62-4ec7-8be2-ef97188837c42026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.fbc48fa5-0bfb-4957-b13c-a56bb7a13b562026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEBluePoint Laboratoriesada390ce-50ea-4de5-be58-5b03caf33c232026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.15a84bd6-b565-4722-bb92-e4c919620a902026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
DOXILDOXORUBICIN HYDROCHLORIDEBaxter Healthcare Corporation917eddf9-1d3f-4abe-8c81-d33b066e5bae2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin Hydrochloride LiposomeDOXORUBICIN HYDROCHLORIDESagent Pharmaceuticalsc8eb4784-36e0-483f-9e5d-af0552e49bb52026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDELupin Pharmaceuticals, Inc.0f8eb9a1-74d0-47fd-94b8-a65b290065212025-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDESagent Pharmaceuticalsae80bd3a-b99a-4e01-a444-b9d05687f00e2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDEAlembic Pharmaceuticals Limitedf8e001f5-441c-47cd-86f6-5d5e3de16bc02025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Incd31d7f58-66d0-4826-b6b5-5914c031965f2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEBluePoint Laboratoriesb8b66e93-0813-4876-b291-8d7c36a998072024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEFresenius Kabi USA, LLCe0349f98-42fa-4003-b6d8-a1db1401b0ef2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEGland Pharma Limited74b14803-afc8-4a2e-ba92-43f1a72025eb2024-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDEActavis Pharma, Inc.33ddfdb1-b4bc-464d-a186-49c4b156279f2024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICINAmneal Pharmaceuticals LLCd928625e-c1ef-4f25-8d25-764c8c6aab672024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208888
ndc (package): 70121-1218-7
ndc (package): 70121-1219-1
ndc (package): 70121-1218-1
ndc (product): 70121-1218
ndc (product): 70121-1219
ndc11 (package): 70121121801
rxcui: 1790095
rxcui: 1872062
spl id: f4a01f55-65d7-401f-ac2f-e1511bf3a429
spl set id: d928625e-c1ef-4f25-8d25-764c8c6aab67
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.f62aa88d-1e25-4049-87ec-99d42edd1d312024-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1790095
unii: 82F2G7BL4E

Reported adverse events (FAERS/openFDA)#

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