FDA.reportPublic FDA data

ATROPINE SULFATE

Product NDC
51662-1311
Requested package NDC
51662-1311-3
11-digit product format
516621311
Labeler code
51662
Product ID
51662-1311_ae808675-c055-7f6c-e053-2995a90a5b49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-10-06
Substance
ATROPINE SULFATE
Active strength
.4 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.4 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
1190776Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77935b57-fcf6-c88a-e053-2a91aa0a0a80Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1311-12020-02-07C16284748780-19d75b9d0-e7d6-f424-e053-dadaa90a57ceATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL
51662-1311-12020-01-31C16284748780-19d75b9d0-e7d6-f424-e053-dadaa90a57ceATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1311-1ATROPINE SULFATE20 mL in 1 VIAL, MULTI-DOSEINJECTION204
51662-1311-2ATROPINE SULFATE1 mL in 1 POUCHINJECTION14
51662-1311-3ATROPINE SULFATE25 in 1 CASEINJECTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1311ATROPINE SULFATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 3 package rows20200910_77935b57-fcf6-c88a-e053-2a91aa0a0a80.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 HealthFirst77935b57-fcf6-c88a-e053-2a91aa0a0a802020-09-04Warnings, Adverse reactionsExact identifier
ndc (package): 51662-1311-3
ndc (product): 51662-1311
ndc11 (package): 51662131103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190776atropine sulfate 0.4 MG/ML Injectable SolutionPSN77935b57-fcf6-c88a-e053-2a91aa0a0a804
1190776atropine sulfate 0.4 MG/ML Injectable SolutionSCD77935b57-fcf6-c88a-e053-2a91aa0a0a804
1190776atropine sulfate 1 MG per 2.5 ML Injectable SolutionSY77935b57-fcf6-c88a-e053-2a91aa0a0a804
1190776atropine sulfate 1.2 MG per 3 ML Injectable SolutionSY77935b57-fcf6-c88a-e053-2a91aa0a0a804
1190776atropine sulfate 2 MG per 5 ML Injectable SolutionSY77935b57-fcf6-c88a-e053-2a91aa0a0a804
1190776atropine sulfate 8 MG per 20 ML Injectable SolutionSY77935b57-fcf6-c88a-e053-2a91aa0a0a804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1311-35166213110325 POUCH in 1 CASE (51662-1311-3) / 1 mL in 1 POUCH (51662-1311-2) 25 pouch2020-09-040000-00-00NoNoCurrent