FDA.reportPublic FDA data

NDC 0641-6006-01 - Atropine Sulfate

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
0641-6006
Requested NDC
0641-6006-01
Package NDCs from labels
0641-6006-01, 0641-6006-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atropine Sulfate Injection, USPHikma Pharmaceuticals USA Inc.2024-04-08HUMAN PRESCRIPTION DRUG LABEL
Atropine Sulfate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-31HUMAN PRESCRIPTION DRUG LABEL
Atropine Sulfate - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-09HUMAN PRESCRIPTION DRUG LABEL
Atropine Sulfate Injection, USP FOR IM, IV, OR SC USE Rx OnlyHenry Schein, Inc.2022-01-09HUMAN PRESCRIPTION DRUG LABEL
ATROPINE SULFATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2020-09-04HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6006-01Atropine Sulfate20 mL in 1 VIALINJECTION204
0641-6006-10Atropine Sulfate10 in 1 CARTONINJECTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6006ATROPINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Legacy NDC, 2 package rows20240410_5d45eb2f-b964-4f64-b277-eef807520466.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6006-01ML - Milliliter0641-60060dd1cebf-afb5-463c-8066-2ae1248537db12012-07-24
0641-6006-10ML - Milliliter0641-600650fad021-aa7f-43ab-b295-6c10da590ef312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5ATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
Atropine SulfateACTIVE INGREDIENT03J5ZE7KA5ATROPINE SULFATE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
ATROPINEACTIVE MOIETY7C0697DR9IATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
AtropineACTIVE MOIETY7C0697DR9IATROPINE SULFATE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RATROPINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

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 19 of 61 · 1,220 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCce0c8c6f-734a-400f-9b60-a3b1e263f25f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDE TABLETSKesin Pharma Corporation2f107592-10c5-ef3b-e063-6394a90a7c0a2025-11-17WarningsExact identifier
unii: 451W47IQ8X
ALUMIZENGARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.Natural Creations, Inc.4760ab09-1141-4944-b840-804ae6d86d2d2025-11-13WarningsExact identifier
unii: 451W47IQ8X
BLISTER HPJUGLANS CINEREA BRANCH BARK/ROOT BARK, POTASSIUM IODIDE, LYCOPODIUM CLAVATUM SPORE, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG.Natural Creations, Inc.e76f05e7-6d7b-4d2e-ba26-bf776bf0e6572025-11-13WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPARSENIC TRIOXIDE, CALCIUM CARBONATE, STRYCHNOS IGNATII SEED, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLANatural Creations, Inc.13d92246-c20e-47a8-b88f-22da876fc5452025-11-13WarningsExact identifier
unii: 451W47IQ8X
ANXIETY II HPACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CAUSTICUM, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAFNatural Creations, Inc.02fa45a5-08e1-41ad-acd4-0f85db07e89e2025-11-13WarningsExact identifier
unii: 451W47IQ8X
Atropine SulfateATROPINE SULFATENorthStar RxLLCf750135c-e6bf-4aa7-a343-87b1204df94f2025-11-12Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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