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 4 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect Rxd9a36478-4788-4107-e053-2a95a90ad6da2025-01-21Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC3f931937-7bc0-416b-e063-6294a90a28b52025-01-03Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATE MONOHYDRATESomerset Therapeutics, LLC84ba1689-3030-48d5-9cce-70b5a24a40332024-12-10Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEAdvanz Pharma (US) Corp.c93cccdc-2f92-4cb3-9d14-06acdd51d94c2024-12-05Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEAdvanz Pharma (US) Corp.4dba30db-7979-455f-a225-24f0a04d744e2024-12-05Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEAccord Healthcare Inc.f3cb74e9-b4ac-4efe-bd8e-8a71970ee7c72024-11-20Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEA-S Medication Solutions1be4dd7d-766c-4b3c-8b86-4f219ab447262024-11-13Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEFresenius Kabi USA, LLC310c8a74-ea24-4357-8099-81e394b1634e2024-10-11Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
STOMAPLEXCARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA (CASSIA ANGUSTIFOLIA), STOMACH (BOVINE), ARSENICUM ALBUM, ATROPINUM SULPHURICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUSBioActive Nutritional, Inc.e1b69e9b-ab47-49f4-bd91-89c935533d672024-09-11WarningsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEBryant Ranch Prepackb3f58de9-1cc8-4bc5-842f-010cc48d35822024-08-23Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATENuCare Pharmaceuticals,Inc.575c38b4-7ec0-6d25-e053-2a91aa0a80fc2024-07-18Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATESomerset Therapeutics, LLCa6fac578-c7bc-4b3c-a454-7889cc8191182024-07-04Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATE MONOHYDRATESomerset Therapeutics, LLCbfdb85b2-86d0-4f32-a8fa-272af48a191c2024-05-24Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAphena Pharma Solutions - Tennessee, LLC14bf7191-580f-76dc-e063-6294a90aed2a2024-04-08Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co. LLC, DBA Health First74106ef7-83bf-47ba-e053-2991aa0aaec12024-03-08Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirst0060b971-19bd-2849-e063-6294a90afca82024-01-28Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirste9fd624a-9abd-dfea-e053-2a95a90a8e9d2024-01-28Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co., LLC, DBA Health First73de9878-a08a-4966-e053-2a91aa0ab0f62024-01-25Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine sulfateATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirst007728fc-f4cb-d519-e063-6394a90ae0332024-01-22Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstc0d0ca2a-4267-41b7-e053-2a95a90a47262024-01-22Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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