FDA.reportPublic FDA data

adenosine

Product NDC
72078-033
11-digit product format
720780033
Labeler code
72078
Product ID
72078-033_c1c149fe-9095-4b2a-a21f-7af3212e0254
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adenosine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA078686
Marketing category
ANDA
Marketing start
2022-04-06
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

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
72078-033-00adenosine2 mL in 1 VIAL, SINGLE-DOSEINJECTION21
72078-033-02adenosine10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72078-033-00ML - Milliliter72078-0337434fff3-01fd-4c3e-b674-4470b0d33f8812022-05-04
72078-033-02ML - Milliliter72078-03358c3b60e-40c4-4f0e-bb5e-5fd73e4894c012022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72078-033ADENOSINE INJECTION [MYLAN INSTITUTIONAL LLC]1Current NDC, Legacy NDC, 2 package rows20220430_c1c149fe-9095-4b2a-a21f-7af3212e0254.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654169adenosine 6 MG in 2 ML InjectionPSNc1c149fe-9095-4b2a-a21f-7af3212e02541
16541692 ML adenosine 3 MG/ML InjectionSCDc1c149fe-9095-4b2a-a21f-7af3212e02541
1654169adenosine 6 MG per 2 ML InjectionSYc1c149fe-9095-4b2a-a21f-7af3212e02541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72078-033-00720780033002 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
72078-033-027207800330210 VIAL, SINGLE-DOSE in 1 CARTON (72078-033-02) / 2 mL in 1 VIAL, SINGLE-DOSE (72078-033-00) 2022-04-060000-00-00NoNoCurrent