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 51 of 61 · 1,220 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: 451W47IQ8X
AnxietyBORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTIINutritional Specialties, Inc.657ed32f-3ac7-4806-96b4-4c7aa0f65e7f2023-04-03WarningsExact identifier
unii: 451W47IQ8X
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum muriaticumSODIUM CHLORIDEBoiron1ef4a040-7bee-11e6-8371-424c583030312023-02-20Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645e304-a71b-5cba-e053-2a91aa0a2d882023-02-20Exact identifier
unii: 451W47IQ8X
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: 451W47IQ8X
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATELeading Pharma, LLC1c188bc9-7c21-4717-94a0-cdfb581fb7762023-02-15Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEA-S Medication Solutions24077113-11b2-4cde-afa7-1a1e364173c22023-02-06Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
HKIATROPINUM SULPHURICUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, CALCAREA CARBONICA, COLOCYNTHIS, COCCUS CACTI, LAPIS ALBUS, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, ORYCTOLAGUS CUNICULUS KIDNEY, RUBIA TINCTORUM, SARSAPARILLA, URTICA URENSSeroyal USA26e048f5-8e87-51e6-e054-00144ff88e882023-01-31WarningsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHikma Pharmaceuticals USA Inc.4c15d3cc-7888-4c82-b3f8-a5d93c5523df2023-01-26Warnings, Adverse reactionsExact identifier
rxcui: 1190776
unii: 03J5ZE7KA5
Natrum muriaticumSODIUM CHLORIDEBoiron86463b98-58f5-7f65-e053-2a91aa0ad3a22023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645f130-6a19-ae73-e053-2991aa0ab05b2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645eb60-65d1-9d6c-e053-2991aa0a94ef2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0e6-5c06-e053-2a91aa0ae83d2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466614-b8ee-2335-e053-2a91aa0aa67c2023-01-23Exact identifier
unii: 451W47IQ8X
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine HydrobromidePHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEIngenus Pharmaceuticals, LLC33bf2df5-bc53-4d57-a9e7-41f3fc0a03f02023-01-12Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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