FDA.reportPublic FDA data

ATROPINE SULFATE

Product NDC
16729-483
11-digit product format
167290483
Labeler code
16729
Product ID
16729-483_4082a1cf-1e1b-6f40-e063-6294a90aec06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Accord Healthcare, Inc.,
Application
ANDA212868
Marketing category
ANDA
Marketing start
2021-07-30
Substance
ATROPINE SULFATE
Active strength
.05 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

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
16729-483-03ATROPINE SULFATE5 mL in 1 SYRINGE, GLASSINJECTION59
16729-483-03ATROPINE SULFATE10 in 1 CARTONINJECTION109
16729-483-31ATROPINE SULFATE5 mL in 1 SYRINGE, GLASSINJECTION59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-483-03ML - Milliliter16729-483c5aa76bb-f70d-4d57-b132-f237c556cd3112021-09-07
16729-483-31ML - Milliliter16729-483b7db4292-e53b-4b17-819a-2e73acf0b39a12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-483ATROPINE SULFATE INJECTION [ACCORD HEALTHCARE, INC.,]8Current NDC, Legacy NDC, 3 package rows20241122_c82cb295-ffce-47d6-97ad-a8aa723f4e4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190551atropine sulfate 0.25 MG in 5 ML Prefilled SyringePSNc82cb295-ffce-47d6-97ad-a8aa723f4e4f9
1190552atropine sulfate 0.5 MG in 5 ML Prefilled SyringePSNc82cb295-ffce-47d6-97ad-a8aa723f4e4f9
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSNc82cb295-ffce-47d6-97ad-a8aa723f4e4f9
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDc82cb295-ffce-47d6-97ad-a8aa723f4e4f9
11905515 ML atropine sulfate 0.05 MG/ML Prefilled SyringeSCDc82cb295-ffce-47d6-97ad-a8aa723f4e4f9
11905525 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDc82cb295-ffce-47d6-97ad-a8aa723f4e4f9
1190551atropine sulfate 0.25 MG per 5 ML Prefilled SyringeSYc82cb295-ffce-47d6-97ad-a8aa723f4e4f9
1190552atropine sulfate 0.5 MG per 5 ML Prefilled SyringeSYc82cb295-ffce-47d6-97ad-a8aa723f4e4f9
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSYc82cb295-ffce-47d6-97ad-a8aa723f4e4f9
1190552atropine sulfate 500 MCG per 5 ML Prefilled SyringeSYc82cb295-ffce-47d6-97ad-a8aa723f4e4f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-483-031672904830310 SYRINGE, GLASS in 1 CARTON (16729-483-03) / 5 mL in 1 SYRINGE, GLASS2021-08-190000-00-00NoNoCurrent
16729-483-31167290483315 mL in 1 SYRINGE, GLASS (16729-483-31) 5 ml2021-07-300000-00-00NoNoCurrent