Atropine Sulfate

Product NDC
16729-526
11-digit product format
167290526
Labeler code
16729
Product ID
16729-526_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
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
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
16729-526-08ML - Milliliter16729-526f7b84c3b-52d9-4b17-8448-2086deab53d612021-02-05
16729-526-63ML - Milliliter16729-526c69df9be-4f9a-4a08-a8d0-1626e3d05b4c12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-526ATROPINE 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
1190795atropine sulfate 1 MG in 1 ML InjectionPSN4a9559e8-7a34-4509-a8cc-ff01256945393
11907951 ML atropine sulfate 1 MG/ML InjectionSCD4a9559e8-7a34-4509-a8cc-ff01256945393
1190795atropine sulfate 1 MG per 1 ML InjectionSY4a9559e8-7a34-4509-a8cc-ff01256945393
1190795atropine sulfate 1 MG in 1 ML InjectionPSNbfc8a727-0cb8-3152-e053-2995a90a28ba2
11907951 ML atropine sulfate 1 MG/ML InjectionSCDbfc8a727-0cb8-3152-e053-2995a90a28ba2
1190795atropine sulfate 1 MG per 1 ML InjectionSYbfc8a727-0cb8-3152-e053-2995a90a28ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-526-031672905260310 VIAL, SINGLE-DOSE in 1 CARTON (16729-526-03) > 1 mL in 1 VIAL, SINGLE-DOSE2022-10-060000-00-00NoNoCurrent
16729-526-081672905260825 VIAL, SINGLE-DOSE in 1 CARTON (16729-526-08) > 1 mL in 1 VIAL, SINGLE-DOSE2021-01-110000-00-00NoNoCurrent
16729-526-63167290526631 VIAL, SINGLE-DOSE in 1 CARTON (16729-526-63) > 1 mL in 1 VIAL, SINGLE-DOSE2021-01-110000-00-00NoNoCurrent