ATROPINE SULFATE

Product NDC
16729-525
11-digit product format
167290525
Labeler code
16729
Product ID
16729-525_d71ab6cc-d30f-32da-e053-2995a90aa7f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Accord Healthcare Inc.
Application
NDA214652
Marketing category
NDA
Marketing start
2021-01-11
Marketing end
0000-00-00
Substance
ATROPINE SULFATE
Active strength
0 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-525-08ML - Milliliter16729-52589ef70eb-9406-4f91-88a5-ed543f50dcfd12021-02-05
16729-525-63ML - Milliliter16729-525027e3448-2410-49cf-b879-f9de53f3e38d12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-525ATROPINE SULFATE INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]6Legacy NDC20250302_d5e07279-48ca-4f83-9633-299e65a7f821.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666781atropine sulfate 0.4 MG in 1 ML InjectionPSNbfc93de4-f731-31fa-e053-2a95a90aadcb2
16667811 ML atropine sulfate 0.4 MG/ML InjectionSCDbfc93de4-f731-31fa-e053-2a95a90aadcb2
1666781atropine sulfate 0.4 MG per 1 ML InjectionSYbfc93de4-f731-31fa-e053-2a95a90aadcb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-525-031672905250310 VIAL, SINGLE-DOSE in 1 CARTON (16729-525-03) > 1 mL in 1 VIAL, SINGLE-DOSE2022-10-060000-00-00NoNoCurrent
16729-525-081672905250825 VIAL, SINGLE-DOSE in 1 CARTON (16729-525-08) > 1 mL in 1 VIAL, SINGLE-DOSE2021-01-110000-00-00NoNoCurrent
16729-525-63167290525631 VIAL, SINGLE-DOSE in 1 CARTON (16729-525-63) > 1 mL in 1 VIAL, SINGLE-DOSE2021-01-110000-00-00NoNoCurrent