FDA.reportPublic FDA data

ATROPINE SULFATE

Product NDC
51662-1208
Requested package NDC
51662-1208-1
11-digit product format
516621208
Labeler code
51662
Product ID
51662-1208_0fcb2857-ba26-920d-e063-6394a90a648f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co., LLC, DBA Health First
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-08-20
Substance
ATROPINE SULFATE
Active strength
.1 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ATROPINE SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
03J5ZE7KA5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1190552Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
73de9878-a08a-4966-e053-2a91aa0ab0f6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1208-1ATROPINE SULFATE5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION57
51662-1208-1ATROPINE SULFATE1 in 1 CARTONINJECTION, SOLUTION17
51662-1208-2ATROPINE SULFATE1 in 1 CARTONINJECTION, SOLUTION17
51662-1208-2ATROPINE SULFATE1 in 1 POUCHINJECTION, SOLUTION17
51662-1208-3ATROPINE SULFATE10 in 1 CASEINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1208ATROPINE SULFATE INJECTION, SOLUTION [HF ACQUISITION CO., LLC, DBA HEALTH FIRST]7Current NDC, Legacy NDC, 5 package rows20240126_73de9878-a08a-4966-e053-2a91aa0ab0f6.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co., LLC, DBA Health First73de9878-a08a-4966-e053-2a91aa0ab0f62024-01-25Warnings, Adverse reactionsExact identifier
ndc (package): 51662-1208-1
ndc (product): 51662-1208
ndc11 (package): 51662120801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190552atropine sulfate 0.5 MG in 5 ML Prefilled SyringePSN73de9878-a08a-4966-e053-2a91aa0ab0f67
11905525 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD73de9878-a08a-4966-e053-2a91aa0ab0f67
1190552atropine sulfate 0.5 MG per 5 ML Prefilled SyringeSY73de9878-a08a-4966-e053-2a91aa0ab0f67
1190552atropine sulfate 500 MCG per 5 ML Prefilled SyringeSY73de9878-a08a-4966-e053-2a91aa0ab0f67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51662-1208-1516621208011 SYRINGE, GLASS in 1 CARTON (51662-1208-1) / 5 mL in 1 SYRINGE, GLASS2018-08-200000-00-00NoNoCurrent