FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
70518-3120
Requested package NDC
70518-3120-0
11-digit product format
705183120
Labeler code
70518
Product ID
70518-3120_4e91c574-0f7d-506b-e063-6394a90abc3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA212461
Marketing category
ANDA
Marketing start
2021-06-14
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212461-001ATROPINE SULFATEATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A212461-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212461-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.46ba6000-b842-449a-8dd4-7bb9dc7a74c52026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461
ndc (package): 70518-3120-0
ndc (product): 70518-3120
ndc11 (package): 70518312000
Atropine SulfateATROPINE SULFATEA-S Medication Solutions739f384f-1a69-4953-93a0-aa6a76de0ecc2026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461
Atropine SulfateATROPINE SULFATEProPharma Distribution3d5c747f-3bf7-2597-e063-6394a90a828c2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461
Atropine SulfateATROPINE SULFATEInternational Medication Systems, Limitedb72d0a82-6163-460f-965a-12f6da47370a2025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstc0d0ca2a-4267-41b7-e053-2a95a90a47262024-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLCc434062a-cd44-e684-e053-2995a90a91c32023-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461

Additional Listing Data#

Finished product
Yes
Brand name base
Atropine Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
03J5ZE7KA5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1190546Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46ba6000-b842-449a-8dd4-7bb9dc7a74c5Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3120-0Atropine Sulfate10 in 1 PACKAGEINJECTION106
70518-3120-0Atropine Sulfate1 in 1 CARTONINJECTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3120ATROPINE SULFATE INJECTION [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20240314_46ba6000-b842-449a-8dd4-7bb9dc7a74c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSN46ba6000-b842-449a-8dd4-7bb9dc7a74c56
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD46ba6000-b842-449a-8dd4-7bb9dc7a74c56
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSY46ba6000-b842-449a-8dd4-7bb9dc7a74c56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3120-07051831200010 CARTON in 1 PACKAGE (70518-3120-0) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE10 carton2021-06-140000-00-00NoNoCurrent