FDA.reportPublic FDA data

N/A

Product NDC
71053-592
11-digit product format
710530592
Labeler code
71053
Product ID
71053-592_4b1cda4c-c117-7a42-e063-6294a90a14e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Injection, 2 mg
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Rafa Laboratories, Ltd.
Application
NDA212319
Marketing category
NDA
Marketing start
2018-07-09
Substance
ATROPINE
Active strength
2 mg/.7mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE2 mg/.7mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7C0697DR9I
Rxcui1190538, 1190540, 1190542

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
71053-592-012024-08-06C16284748780-1ba0f9c33-5a72-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ATROPINE safely and effectively. See full prescribing information for ATROPINE. ATROPINE injection, for intramuscular use Initial U.S. Approval: 1973
71053-592-012023-01-30C16284748780-1ba0f9c33-5a72-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ATROPINE safely and effectively. See full prescribing information for ATROPINE. ATROPINE injection, for intramuscular use Initial U.S. Approval: 1973
71053-592-012021-12-06C16284748780-1ba0f9c33-5a72-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ATROPINE safely and effectively. See full prescribing information for ATROPINE. ATROPINE injection, for intramuscular use Initial U.S. Approval: 1973
71053-592-012021-01-29C16284748780-1ba0f9c33-5a72-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ATROPINE safely and effectively. See full prescribing information for ATROPINE. ATROPINE injection, for intramuscular use Initial U.S. Approval: 1973

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71053-592-01N/A40 in 1 CARTONINJECTION408
71053-592-01N/A480 in 1 BOXINJECTION4808

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71053-592N/A (ATROPINE SULFATE INJECTION USP, 1 MG/0.7 ML) INJECTION N/A (ATROPINE SULFATE INJECTION USP, 0.5 MG/0.7 ML) INJECTION N/A (ATROPINE INJECTION, 2 MG) INJECTION [RAFA LABORATORIES, LTD.]7Current NDC, Legacy NDC, 2 package rows20240807_4a4fa6e8-0e0a-0e76-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190538atropine sulfate 0.5 MG in 0.7 ML Auto-InjectorPSN4a4fa6e8-0e0a-0e76-e054-00144ff8d46c8
1190540atropine sulfate 1 MG in 0.7 ML Auto-InjectorPSN4a4fa6e8-0e0a-0e76-e054-00144ff8d46c8
1190542atropine sulfate 2 MG in 0.7 ML Auto-InjectorPSN4a4fa6e8-0e0a-0e76-e054-00144ff8d46c8
11905380.7 ML atropine sulfate 0.714 MG/ML Auto-InjectorSCD4a4fa6e8-0e0a-0e76-e054-00144ff8d46c8
11905400.7 ML atropine sulfate 1.43 MG/ML Auto-InjectorSCD4a4fa6e8-0e0a-0e76-e054-00144ff8d46c8
11905420.7 ML atropine sulfate 2.86 MG/ML Auto-InjectorSCD4a4fa6e8-0e0a-0e76-e054-00144ff8d46c8
1190538atropine sulfate 0.5 MG (atropine 0.42 MG) per 0.7 ML Auto-InjectorSY4a4fa6e8-0e0a-0e76-e054-00144ff8d46c8
1190540atropine sulfate 1 MG (atropine 0.84 MG) per 0.7 ML Auto-InjectorSY4a4fa6e8-0e0a-0e76-e054-00144ff8d46c8
1190542atropine sulfate 2 MG (atropine base 1.67 MG) per 0.7 ML Auto-InjectorSY4a4fa6e8-0e0a-0e76-e054-00144ff8d46c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71053-592-0171053059201480 CARTON in 1 BOX (71053-592-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE480 carton2018-07-090000-00-00NoNoCurrent