ATROPINE SULFATE
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- ATROPINE SULFATE
- Generic name
- ATROPINE SULFATE
- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 77935b57-fcf6-c88a-e053-2a91aa0a0a80
- SPL ID
- ae808675-c055-7f6c-e053-2995a90a5b49
- Version
- 4
- Effective date
- 2020-09-04
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:15:04
| Harmonized routes |
|---|
| INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| brand name | ATROPINE SULFATE | openfda.brand_name | |
| generic name | ATROPINE SULFATE | openfda.generic_name | |
| manufacturer name | HF Acquisition Co LLC, DBA HealthFirst | openfda.manufacturer_name | |
| ndc | package | 51662-1311-3 | openfda.package_ndc |
| ndc | package | 51662-1311-1 | openfda.package_ndc |
| ndc | package | 51662-1311-2 | openfda.package_ndc |
| ndc | product | 51662-1311 | openfda.product_ndc |
| ndc11 | package | 51662131101 | derived:openfda.package_ndc |
| ndc11 | package | 51662131102 | derived:openfda.package_ndc |
| ndc11 | package | 51662131103 | derived:openfda.package_ndc |
| rxcui | 1190776 | openfda.rxcui | |
| spl id | ae808675-c055-7f6c-e053-2995a90a5b49 | id | |
| spl set id | 77935b57-fcf6-c88a-e053-2a91aa0a0a80 | set_id | |
| unii | 03J5ZE7KA5 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Atropine is a highly potent drug and due care is essential to avoid overdosage, especially with intravenous administration. Pediatric populations are more susceptible than adults to the toxic effects of anticholinergic agents. Atropine I.V. decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia. Atropine is not removed by dialysis. This drug is effective in very low dosage and overdose may cause permanent damage or death, especially in children. This product contains Benzyl Alcohol which has been associated with a fatal gasping syndrome in infants and neonates.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Individual tolerance varies greatly, but these systemic doses are likely to produce the following effects: A scarlatiniform rash may occur. Atropine may produce fever, particularly in children, through inhibition of heat loss by evaporation. Although large doses of atropine may cause an alarming condition, recovery is usual. ADVERSE EVENT TABEL
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.