NDC 0641-6164-01 - CAFCIT

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
0641-6164
Requested NDC
0641-6164-01
Package NDCs from labels
0641-6164-01, 0641-6164-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Caffeine Citrate Injection, USPHikma Pharmaceuticals USA Inc.2026-03-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6164-01CAFCIT3 mL in 1 VIALINJECTION317
0641-6164-10CAFCIT10 in 1 BOXINJECTION1017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6164CAFCIT (CAFFEINE CITRATE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]16Legacy NDC, 2 package rows20240606_f9feb925-e1b8-41bc-b9c5-89198f07c0e9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6164-01ML - Milliliter0641-6164a48d6a41-0f87-43b3-a175-3b38ba2dc2b812015-06-09
0641-6164-10ML - Milliliter0641-6164f736b58f-d766-4aee-90ed-6afa8fb9a8ee12015-06-09

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 12 of 12 · 240 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Caffeine CitrateCAFFEINE CITRATESun Pharmaceutical Industries, Inc.cc632825-e0a4-4524-8d7d-ce926efab3d62020-12-12Warnings, Adverse reactionsExact identifier
unii: U26EO4675Q
GUNA FLAM RELIEFACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -Guna spaaf5a9c74-e1c7-6574-e053-2995a90a3d102020-09-15WarningsExact identifier
unii: 2968PHW8QP
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Caffeine CitrateCAFFEINE CITRATESun Pharmaceutical Industries, Inc.d06d3810-9923-4199-be5e-ee5ee086b0a42019-03-01Warnings, Adverse reactionsExact identifier
unii: U26EO4675Q
Caffeine CitrateCAFFEINE CITRATEFresenius Kabi USA, LLCb4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e2019-02-28Warnings, Adverse reactionsExact identifier
unii: U26EO4675Q
GUNA-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
unii: 2968PHW8QP
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
caffeine citrateCAFFEINE CITRATEExela Pharma Sciences, LLCf423a220-e7bf-4d24-bc52-bafc1864265b2015-03-30Warnings, Adverse reactionsExact identifier
unii: U26EO4675Q
caffeine citrateCAFFEINE CITRATEExela Pharma Sciences, LLC5d05ebf4-fd27-3bd1-5634-b41e33abc41f2015-03-26Warnings, Adverse reactionsExact identifier
unii: U26EO4675Q

Reported adverse events (FAERS/openFDA)#

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