FDA.reportPublic FDA data

ATROPEN Auto-Injector

Product NDC
11704-104
11-digit product format
117040104
Labeler code
11704
Product ID
11704-104_f1736bb6-219c-48dd-969d-f26f6fbad350
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atropine
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Meridian Medical Technologies LLC
Application
NDA017106
Marketing category
NDA
Marketing start
2003-06-19
Substance
ATROPINE
Active strength
.5 mg/.7mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ATROPEN Auto-Injector
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE.5 mg/.7mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7C0697DR9I
Rxcui1190536, 1190538, 1190540, 1190542, 1190608, 1190611, 1190614, 1190620

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
11704-104-01ATROPEN Auto-Injector0.7 mL in 1 SYRINGE, PLASTICINJECTION0.712

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11704-104-01ML - Milliliter11704-104304d6ccf-24ef-4d92-911c-ad00468adc1d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atropine sulfateACTIVE INGREDIENT03J5ZE7KA5ATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]1
AtropineACTIVE MOIETY7C0697DR9IATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]1
Citric AcidINACTIVE INGREDIENT2968PHW8QPATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]1
Phenol CrystallineINACTIVE INGREDIENTATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11704-104ATROPEN AUTO-INJECTOR (ATROPINE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES LLC]12Current NDC, Legacy NDC, 1 package rows20220921_e2d4307d-da8f-49f5-aac0-02355dd9ffb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190608AtroPen 0.25 MG in 0.3 ML Auto-InjectorPSNe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190611AtroPen 0.5 MG in 0.7 ML Auto-InjectorPSNe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190614AtroPen 1 MG in 0.7 ML Auto-InjectorPSNe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190620AtroPen 2 MG in 0.7 ML Auto-InjectorPSNe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190536atropine sulfate 0.25 MG in 0.3 ML Auto-InjectorPSNe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190538atropine sulfate 0.5 MG in 0.7 ML Auto-InjectorPSNe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190540atropine sulfate 1 MG in 0.7 ML Auto-InjectorPSNe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190542atropine sulfate 2 MG in 0.7 ML Auto-InjectorPSNe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11906080.3 ML atropine sulfate 0.833 MG/ML Auto-Injector [Atropen]SBDe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11906110.7 ML atropine sulfate 0.714 MG/ML Auto-Injector [Atropen]SBDe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11906140.7 ML atropine sulfate 1.43 MG/ML Auto-Injector [Atropen]SBDe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11906200.7 ML atropine sulfate 2.86 MG/ML Auto-Injector [Atropen]SBDe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11905360.3 ML atropine sulfate 0.833 MG/ML Auto-InjectorSCDe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11905380.7 ML atropine sulfate 0.714 MG/ML Auto-InjectorSCDe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11905400.7 ML atropine sulfate 1.43 MG/ML Auto-InjectorSCDe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11905420.7 ML atropine sulfate 2.86 MG/ML Auto-InjectorSCDe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11906080.3 ML Atropen 0.833 MG/ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11906110.7 ML Atropen 0.714 MG/ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11906140.7 ML Atropen 1.43 MG/ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
11906200.7 ML Atropen 2.86 MG/ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190608AtroPen 0.25 MG (atropine base 0.21 MG) per 0.3 ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190611AtroPen 0.5 MG (atropine base 0.42 MG) per 0.7 ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190614AtroPen 1 MG (atropine base 0.84 MG) per 0.7 ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190620AtroPen 2 MG (atropine base 1.67 MG) per 0.7 ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190536atropine sulfate 0.25 MG (atropine 0.21 MG) per 0.3 ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190538atropine sulfate 0.5 MG (atropine 0.42 MG) per 0.7 ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190540atropine sulfate 1 MG (atropine 0.84 MG) per 0.7 ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712
1190542atropine sulfate 2 MG (atropine base 1.67 MG) per 0.7 ML Auto-InjectorSYe2d4307d-da8f-49f5-aac0-02355dd9ffb712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11704-104-0111704010401.7 mL in 1 SYRINGE, PLASTIC (11704-104-01) 2003-06-190000-00-00NoNoCurrent