NDC 67184-0504-01 - 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: 67184-0504
Requested NDC: 67184-0504-01
Package NDCs from labels: 67184-0504-1, 67184-0504-01
Manufacturer: Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.
Effective date: 2021-08-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Pemetrexed	Qilu Pharmaceutical Co., Ltd. \| Qilu Pharmaceutical (Hainan) Co., Ltd.	2021-08-13	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67184-0504-1	2022-06-07	C162847	48780-1	9d75b9d0-0bdd-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004
67184-0504-1	2020-01-31	C162847	48780-1	9d75b9d0-0bdd-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67184-0504-1	Pemetrexed	20 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	20		5
67184-0504-1	Pemetrexed	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67184-0504	PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.]	5	Current NDC, Legacy NDC, 2 package rows	20220608_46a9b89d-7135-4e0c-b8e4-52580554769b.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 4 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pemetrexed	PEMETREXED DISODIUM	Zydus Lifesciences Limited	6986de29-b077-48ac-ad2b-0cc478f72d89	2022-05-26		Exact identifier rxcui: 1728077 rxcui: 1728072
BHI Hemorrhoid	HORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFUR	MediNatura Inc	d7df7d3e-48ad-4f58-aef5-a7bd48d2f191	2022-01-05	Warnings	Exact identifier unii: QTT17582CB
Joette Calabrese Survivalist Kit	ABROT 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 VIP	OHM PHARMA INC.	1ac2a2c4-704e-4efa-aa44-acc71d300f70	2021-12-29	Warnings	Exact identifier unii: QTT17582CB
Pemetrexed	PEMETREXED DISODIUM	Qilu Pharmaceutical Co., Ltd.	46a9b89d-7135-4e0c-b8e4-52580554769b	2021-08-13	Warnings, Adverse reactions	Exact identifier application number: ANDA204890 ndc (package): 67184-0503-1 ndc (package): 67184-0504-1 ndc (product): 67184-0503 ndc (product): 67184-0504 ndc11 (package): 67184050401 rxcui: 1728077 rxcui: 1728072 spl id: 0dc735ab-c4c9-4e19-bb80-8a439be7208c spl set id: 46a9b89d-7135-4e0c-b8e4-52580554769b unii: F4GSH45R4C
Fungisode	ARSENICUM 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, SULPHUR	Seroyal USA	55c5dfc4-3757-6ac2-e054-00144ff88e88	2021-07-22	Warnings	Exact identifier unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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