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 34 of 61 · 1,220 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-73SULFURIC ACID, SILVER, ARNICA MONTANA, BRYONIA ALBA ROOT, CAUSTICUM, AND RHODODENDRON TOMENTOSUM LEAFY TWIGDNA Labs, Inc.46fe6da9-404b-4f73-8fe8-c48c5e028ffe2025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-115CAUSTICUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, IODINE, ARSENIC TRIOXIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, ALUMINUM, ANTIMONY TRISULFIDE, STRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, SULFURIC ACID, CALCIUM SULFIDE, AND SILVER NITRATEDNA Labs, Inc.247a9133-fe4b-42a0-b3f3-7cb62eaec8c42025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: 451W47IQ8X
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
A-36BOS TAURUS ADRENAL GLAND, AGRIMONIA EUPATORIA, BELLIS PERENNIS, CAMPHOR (NATURAL), MATRICARIA CHAMOMILLA, EQUISETUM HYEMALE, FRAXINUS AMERICANA BARK, FORMICA RUFA, HISTAMINE DIHYDROCHLORIDE, IODINE, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, SODIUM CHLORIDE, ANEMONE PULSATILLA, SALIX NIGRA BARK, AND TOBACCO LEAFDNA Labs, Inc.161c4738-9ead-4687-9f5a-029d5a496e072025-01-09WarningsExact identifier
unii: 451W47IQ8X
AM-11ARNICA MONTANA, SODIUM CHLORIDE, AND APIS MELLIFERADNA Labs, Inc.c072811b-6259-4b22-b364-50369dc68fb02025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-13CEANOTHUS AMERICANUS LEAF, URTICA URENS, SODIUM CHLORIDE, LACHESIS MUTA WHOLE, CINCHONA OFFICINALIS BARK, LYCOPODIUM CLAVATUM WHOLE, FERRIC CHLORIDE HEXAHYDRATE, AND SUS SCROFA SPLEENDNA Labs, Inc.146c5465-bcd9-4057-8975-dc1088b9971b2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-10SODIUM CHLORIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, IODINE, LYCOPODIUM CLAVATUM WHOLE, AND BOS TAURUS PITUITARY GLAND, POSTERIORDNA Labs, Inc.264d8093-70f3-43a5-bfc4-b719bb3e45e62025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-14FUCUS VESICULOSUS, SODIUM CHLORIDE, LYCOPUS VIRGINICUS, SPONGIA OFFICINALIS SKELETON, ROASTED, POTASSIUM IODIDE, CALCIUM IODIDE, THYROID, UNSPECIFIED, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS THYMUS, AND SUS SCROFA SPLEENDNA Labs, Inc.3d64739c-5d61-4e88-8612-d5f6994f1c3c2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 451W47IQ8X
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst8dfb05c0-77e8-2fa1-e053-2a95a90a3d332025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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