FDA.reportPublic FDA data

adenosine

Product NDC
67457-855
11-digit product format
674570855
Labeler code
67457
Product ID
67457-855_a807e222-e981-48ee-8d2c-b226b90347bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adenosine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA078686
Marketing category
ANDA
Marketing start
2018-05-08
Substance
ADENOSINE
Active strength
3 mg/mL
Pharmacologic classes
Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
adenosine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADENOSINE3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK72T3FS567
Rxcui1654169, 1654186

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-855-00adenosine2 mL in 1 VIAL, SINGLE-DOSEINJECTION23
67457-855-02adenosine10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-855-00ML - Milliliter67457-85503f908b7-3a70-4263-ad11-dba46237d58512019-08-06
67457-855-02ML - Milliliter67457-855bd1b0f07-41b7-4b3e-9794-fbd168680f1512018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-855ADENOSINE INJECTION [MYLAN INSTITUTIONAL LLC]3Current NDC, Legacy NDC, 2 package rows20240601_d2d06ee6-c89f-49f7-9e2c-46d33ce877a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654186adenosine 12 MG in 4 mL InjectionPSNd2d06ee6-c89f-49f7-9e2c-46d33ce877a93
1654169adenosine 6 MG in 2 ML InjectionPSNd2d06ee6-c89f-49f7-9e2c-46d33ce877a93
16541692 ML adenosine 3 MG/ML InjectionSCDd2d06ee6-c89f-49f7-9e2c-46d33ce877a93
16541864 ML adenosine 3 MG/ML InjectionSCDd2d06ee6-c89f-49f7-9e2c-46d33ce877a93
1654186adenosine 12 MG per 4 ML InjectionSYd2d06ee6-c89f-49f7-9e2c-46d33ce877a93
1654169adenosine 6 MG per 2 ML InjectionSYd2d06ee6-c89f-49f7-9e2c-46d33ce877a93
1654169adenosine 6 MG in 2 ML InjectionPSNa2a2fef9-d305-40ba-e053-2a95a90a0c542
16541692 ML adenosine 3 MG/ML InjectionSCDa2a2fef9-d305-40ba-e053-2a95a90a0c542
1654169adenosine 6 MG per 2 ML InjectionSYa2a2fef9-d305-40ba-e053-2a95a90a0c542
1654169adenosine 6 MG in 2 ML InjectionPSNfa6eb0f8-7c41-2e17-e053-6294a90ac8ca1
16541692 ML adenosine 3 MG/ML InjectionSCDfa6eb0f8-7c41-2e17-e053-6294a90ac8ca1
1654169adenosine 6 MG per 2 ML InjectionSYfa6eb0f8-7c41-2e17-e053-6294a90ac8ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-855-00674570855002 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
67457-855-026745708550210 VIAL, SINGLE-DOSE in 1 CARTON (67457-855-02) / 2 mL in 1 VIAL, SINGLE-DOSE (67457-855-00) 2018-05-080000-00-00NoNoCurrent