FDA.reportPublic FDA data

N/A

Product NDC
71053-591
11-digit product format
710530591
Labeler code
71053
Product ID
71053-591_4b1cda4c-c117-7a42-e063-6294a90a14e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate Injection USP, 1 mg/0.7 mL
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Rafa Laboratories, Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-03-09
Substance
ATROPINE
Active strength
1 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71053-591-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71053-591-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71053-591-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71053-591-011332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE1 mg/.7mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7C0697DR9IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1190538Internal RxNorm lookup
1190540Internal RxNorm lookup
1190542Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a4fa6e8-0e0a-0e76-e054-00144ff8d46cAvailable on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2024-08-06These 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
2023-01-30These 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
2021-12-06These 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
2021-01-29These 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
71053-591-01N/A0.7 mL in 1 SYRINGEINJECTION0.78

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71053-591N/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, 1 package rows20240807_4a4fa6e8-0e0a-0e76-e054-00144ff8d46c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
N/AATROPINE SULFATE INJECTION USP, 0.5 MG/0.7 MLRafa Laboratories, Ltd.4a4fa6e8-0e0a-0e76-e054-00144ff8d46c2026-02-18Warnings, Adverse reactionsExact identifier
ndc (product): 71053-591

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71053-591-0171053059101.7 mL in 1 SYRINGE (71053-591-01) 2018-03-090000-00-00NoNoCurrent