FDA.reportPublic FDA data

NDC 11695-7000 - 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
11695-7000
Package NDCs from labels
11695-7000-1
Manufacturer
Covetrus North America
Effective date
2021-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ATROPINE SULFATE - Covetrus North AmericaCovetrus North America2021-07-01PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11695-7000-1ATROPINE SULFATE100 mL in 1 VIALINJECTION, SOLUTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11695-7000ATROPINE SULFATE (ATROPINE SULFATE) INJECTION, SOLUTION [COVETRUS NORTH AMERICA]11 package rows20241102_083cab01-5c45-4ba6-b853-a00084686a8e.zip

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 1 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.8663ff94-8bea-4061-9fd5-3ab2e85e862e2026-09-04Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.532aa441-92ec-42d6-862a-639f8cfe99512026-08-31Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
AtropineATROPINE SULFATEGland Pharma Limiteda116af5c-ba4c-408c-9a02-4bc33772aa8d2026-08-03Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEA-S Medication Solutionsf94a0189-40d2-42e0-8d2b-c9dc433faad12026-07-29Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.0f5b0961-efe7-42c3-898e-2f7fc7fc90b12026-07-28Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirst768dc21a-b7d9-144c-e053-2991aa0af8892026-06-19Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEREMEDYREPACK INC.3d0e2877-7a74-433f-8a31-e3e54aa9dc9f2026-06-10Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATERedpharm Drug5342df5c-12bb-565c-e063-6294a90a4ade2026-06-02Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEBryant Ranch Prepackbd08ed90-dd26-4629-83c0-0f75af6ebb952026-05-21Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
PhenohytroPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDEATLANTIC BIOLOGICALS CORP.a5aaf1db-1938-4073-9da4-c47f959d013e2026-05-19Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHospira, Inc.ad8916e7-206e-409e-2582-30d072845dd42026-05-18Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine sulfateATROPINE SULFATEEdenbridge Pharmaceuticals LLC.b39f5876-5d6f-4a8f-bd24-bd4be24ff5682026-05-07Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPreferred Pharmaceuticals Inc.46d5b27b-a710-4767-b308-4f673ddb354c2026-04-06Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.46ba6000-b842-449a-8dd4-7bb9dc7a74c52026-04-03Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
MotofenDIFENOXIN AND ATROPINE SULFATELegacy Pharma USA Inc.1fa11c67-5492-469c-9475-6bfa0e5e9ff82026-03-23Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
atropine sulfateATROPINE SULFATEAlcon Laboratories, Inc.c8093125-ed1a-4eb6-9c81-52c5c73764812026-03-13Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Liver Tonic IIBOLDO, CARDUUS MARIANUS, CURCUMA LONGA, ECHINACEA (ANGUSTIFOLIA), TARAXACUM OFFICINALE MAGNESIA PHOSPHORICA, GALLBLADDER (BOVINE), HEPAR BOVINE, AMMI VISNAGA, ATROPINUM SULPHURICUM, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, PODOPHYLLINUMBioActive Nutritional, Inc.b3bdb177-e2d7-4fd6-b0b7-8174fc53fb6c2026-03-11WarningsExact identifier
unii: 03J5ZE7KA5
AtropineATROPINE SULFATEApotex Corp.127a7e32-a150-01d6-a66a-b7708d85809f2026-03-10Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
LomotilDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPfizer Laboratories Div Pfizer Incf170584a-1072-4fd7-b1dc-6756703483b92026-02-23Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEMylan Pharmaceuticals Inc.83bcc2fb-6fb0-4f0e-8e66-592d327684ec2026-02-23Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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