FDA.reportPublic FDA data

NDC 70710-1674-01 - pemetrexed

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
70710-1674
Requested NDC
70710-1674-01
Package NDCs from labels
70710-1674-1, 70710-1674-01
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Hospira Oncology Private Limited
Effective date
2022-05-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
pemetrexed - Zydus Pharmaceuticals USA Inc. | Zydus Hospira Oncology Private LimitedZydus Pharmaceuticals USA Inc. | Zydus Hospira Oncology Private Limited2022-05-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1674-1pemetrexed40 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,401
70710-1674-1pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1674PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, Legacy NDC, 2 package rows20220527_363665ca-db15-4123-84ac-0ae66b5f1363.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1674-1EA - Each70710-1674e526559b-1639-467c-a8e5-880c7a72d0a912022-06-06

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 4 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PemetrexedPEMETREXED DISODIUMBluePoint Laboratoriesc9f34c00-1176-4f44-8cff-bae5bdc0c40f2022-12-08Warnings, Adverse reactionsExact identifier
rxcui: 1728077
rxcui: 1728072
Pemetrexed disodiumPEMETREXED DISODIUMDr. Reddys Laboratories Inc1d8bcf03-e055-a274-7844-ae9a523e3c4c2022-09-30Warnings, Adverse reactionsExact identifier
rxcui: 1728077
rxcui: 2601728
rxcui: 1728072
unii: 2PKU919BA9
pemetrexedPEMETREXED DISODIUMZydus Pharmaceuticals USA Inc.363665ca-db15-4123-84ac-0ae66b5f13632022-05-26Warnings, Adverse reactionsExact identifier
application number: ANDA214073
ndc (package): 70710-1655-1
ndc (package): 70710-1654-1
ndc (package): 70710-1674-1
ndc (product): 70710-1655
ndc (product): 70710-1674
ndc (product): 70710-1654
ndc11 (package): 70710167401
rxcui: 1728077
rxcui: 2601728
rxcui: 1728072
spl id: bf1de3fa-e7f8-4beb-beeb-6272709d13f2
spl set id: 363665ca-db15-4123-84ac-0ae66b5f1363
unii: 2PKU919BA9
pemetrexedPEMETREXED DISODIUMZydus Lifesciences Limited6986de29-b077-48ac-ad2b-0cc478f72d892022-05-26Exact identifier
application number: ANDA214073
rxcui: 1728077
rxcui: 2601728
rxcui: 1728072
unii: 2PKU919BA9
BHI HemorrhoidHORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFURMediNatura Incd7df7d3e-48ad-4f58-aef5-a7bd48d2f1912022-01-05WarningsExact identifier
unii: QTT17582CB
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: QTT17582CB
PemetrexedPEMETREXED DISODIUMQilu Pharmaceutical Co., Ltd.46a9b89d-7135-4e0c-b8e4-52580554769b2021-08-13Warnings, Adverse reactionsExact identifier
rxcui: 1728077
rxcui: 1728072
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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