FDA.reportPublic FDA data

NDC 54925-063 - 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
54925-063
Package NDCs from labels
54925-063-10
Manufacturer
Med-Pharmex, Inc
Effective date
2008-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atropine Sulfate - Med-Pharmex, IncMed-Pharmex, Inc2008-04-01PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5ATROPINE SULFATE INJECTION, SOLUTION [MED-PHARMEX, INC]1
ATROPINEACTIVE MOIETY7C0697DR9IATROPINE SULFATE INJECTION, SOLUTION [MED-PHARMEX, 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 · 113 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
A09 FEMALE BALANCEARGENTUM NITRICUM, ATROPINUM SULPHURICUM, AURUM MURIATICUM NATRONATUM, BOS TAURUS OVARY, BOS TAURUS PANCREAS, BOS TAURUS PITUITARUM POSTERIUM, BOS TAURUS UTERUS, CIMICIFUGA RACEMOSA, ESTRONE, HELONIAS DIOICA, PROGESTERONE, PULSATILLA VULGARIS, SABINA, SEPIA, SEQUOIADENDRON GIGANTEUM WHOLE, SUS SCROFA PINEAL GLAND, SUS SCROFA SPLEEN, THIOSINAMINUM, THYROIDINUM, VIBURNUM OPULUSApex Energetics Inc.b8e1ba2a-f80f-158e-e053-2a95a90aacd12024-01-08WarningsExact identifier
unii: 03J5ZE7KA5
AtropineATROPINE SULFATEA-S Medication Solutions1b2d030e-c0ec-484b-a228-76011702cdd02024-01-02Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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