Adenosine

Product NDC
68083-157
11-digit product format
680830157
Labeler code
68083
Product ID
68083-157_acdf6567-6d2d-4adc-9ba2-c4528fe02a05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adenosine
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA206778
Marketing category
ANDA
Marketing start
2017-01-13
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
68083-157-10Adenosine4 mL in 1 VIALSOLUTION43
68083-157-10Adenosine10 in 1 CARTONSOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-157ADENOSINE SOLUTION [GLAND PHARMA LIMITED]3Current NDC, Legacy NDC, 2 package rows20180221_1b701a86-3c4e-4c13-bf9e-aa9e73774c20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654186adenosine 12 MG in 4 mL InjectionPSN1b701a86-3c4e-4c13-bf9e-aa9e73774c203
1654169adenosine 6 MG in 2 ML InjectionPSN1b701a86-3c4e-4c13-bf9e-aa9e73774c203
16541692 ML adenosine 3 MG/ML InjectionSCD1b701a86-3c4e-4c13-bf9e-aa9e73774c203
16541864 ML adenosine 3 MG/ML InjectionSCD1b701a86-3c4e-4c13-bf9e-aa9e73774c203
1654186adenosine 12 MG per 4 ML InjectionSY1b701a86-3c4e-4c13-bf9e-aa9e73774c203
1654169adenosine 6 MG per 2 ML InjectionSY1b701a86-3c4e-4c13-bf9e-aa9e73774c203

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-157-106808301571010 VIAL in 1 CARTON (68083-157-10) / 4 mL in 1 VIAL10 vial2017-01-130000-00-00NoNoCurrent