FDA.reportPublic FDA data

NDC 58005-307 - 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
58005-307
Package NDCs from labels
58005-307-04
Manufacturer
Sparhawk Laboratories, Inc.
Effective date
2017-02-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ATROPINE SULFATE LA 15 MGSparhawk Laboratories, Inc.2017-02-01PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58005-307ATROPINE SULFATE INJECTION, SOLUTION [SPARHAWK LABORATORIES, INC.]2Unmatched20170201_3ea6a37f-2c3b-4ea1-b00a-d15b7bc293c5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5ATROPINE SULFATE INJECTION, SOLUTION [SPARHAWK LABORATORIES, INC.]1
ATROPINEACTIVE MOIETY7C0697DR9IATROPINE SULFATE INJECTION, SOLUTION [SPARHAWK LABORATORIES, INC.]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 6 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopto AtropineATROPINE SULFATEAlcon Laboratories, Inc.20491566-e6eb-8d4a-3083-77ea429f7bc42022-10-07Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEVistaPharm, LLC11a48ba9-576b-4e8c-9536-6e83636d69302022-07-07Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEWinder Laboratories LLC7344a2d2-1f8a-4c5a-90e3-181b919c0c7a2022-05-31Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEProficient Rx LP593f2d01-5d24-450e-a6cf-204b7420f9712022-03-01Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEAmerican Regent, Inc.6fee1727-52b7-4f73-ab45-ef47d6a1c5bb2021-09-01Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
HADATROPINUM SULPHURICUM, BERBERIS VULGARIS, BRYONIA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA ANGUSTIFOLIA, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, ORYCTOLAGUS CUNICULUS (RABBIT) ADRENAL GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) SPLEEN, ZINGIBER OFFICINALE (GINGER) RHIZOMESeroyal USA25665b4f-82ec-11be-e054-00144ff88e882021-07-22WarningsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirst77935b57-fcf6-c88a-e053-2a91aa0a0a802020-09-04Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEBausch & Lomb Incorporatedc0a56d60-0914-42b1-af59-c56afe93d18c2020-04-02Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEProficient Rx LPc832ef16-a06e-4e47-9df3-ab33bdfa6e562020-03-01Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
PhenohytroPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEWinder Laboratories, LLC27c8baac-f8ce-46d8-8a0f-ff769dd408d92019-12-27Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
PhenohytroPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDEWinder Laboratories LLC29be31ef-108e-4b45-9ecc-b6d671da28262019-10-04Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
GUNA-SPASMATROPINE SULFATE - BERBERIS VULGARIS ROOT BARK - CHELIDONIUM MAJUS - COBALT - CULTIVATED MUSHROOM - GELSEMIUM SEMPERVIRENS ROOT - INTERLEUKIN-10 - MAGNESIUM - MELATONIN - METENKEFALIN - SUS SCROFA SYMPATHETIC NERVE - SUS SCROFA VAGUS NERVE - WATERMELON - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa9d46b4d1-c8e8-40a3-8a32-1cc3d8f602ed2018-12-21WarningsExact identifier
unii: 03J5ZE7KA5
GB-ToneAMMI VISNAGA, ATROPINUM SULPHURICUM, BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA, FEL TAURI, HEPAR SUIS, HYDRASTIS CANADENSIS, LEPTANDRA VIRGINICA, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, PODOPHYLLUM PELTATUM, TARAXACUM OFFICINALEEnergetix Corp5620a1dc-b59c-4489-a548-20f3e488287f2018-07-11WarningsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAphena Pharma Solutions - Tennessee, LLC435e5e75-5a4c-4806-8d9e-d4be3fef92292017-08-31Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAphena Pharma Solutions - Tennessee, LLC59934cee-4e1f-4958-9e97-6de53b39daf32016-06-10Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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