FDA.reportPublic FDA data

NDC 0641-6182-01 - Orphenadrine citrate

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
0641-6182
Requested NDC
0641-6182-01
Package NDCs from labels
0641-6182-01, 0641-6182-10, 0641-6182-25
Manufacturer
REMEDYREPACK INC.
Effective date
2024-12-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ORPHENADRINE CITRATE INJECTION, USPREMEDYREPACK INC.2024-12-03HUMAN PRESCRIPTION DRUG LABEL
ORPHENADRINE CITRATE INJECTION, USPHikma Pharmaceuticals USA Inc.2024-08-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6182-01Orphenadrine citrate2 mL in 1 VIALINJECTION25
0641-6182-10Orphenadrine citrate10 in 1 BOXINJECTION105
0641-6182-25Orphenadrine citrate25 in 1 BOXINJECTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6182ORPHENADRINE CITRATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 3 package rows20240809_ed406e8a-ec00-4711-ae2b-3c5af4f15438.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6182-01ML - Milliliter0641-61825a19407b-dbd6-4797-b8d8-790c93f12ff212017-12-14
0641-6182-10ML - Milliliter0641-6182284eaedf-e0c9-4cbb-8ffd-b2aef877b3f312017-12-14
0641-6182-25ML - Milliliter0641-61822bd52cb8-76de-4bc5-ae3b-28e12563bf9d12024-09-09

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 53 of 53 · 1,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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