ATROPINE SULFATE

Product NDC
51662-1311
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 Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5
Rxcui1190776

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#

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

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
51662-1311-15166213110120 mL in 1 VIAL, MULTI-DOSE (51662-1311-1) 20 ml2018-10-060000-00-00NoNoCurrent
51662-1311-2516621311021 mL in 1 POUCH1 mlHistorical
51662-1311-35166213110325 POUCH in 1 CASE (51662-1311-3) / 1 mL in 1 POUCH (51662-1311-2) 25 pouch2020-09-040000-00-00NoNoCurrent