FDA.reportPublic FDA data

Adenosine

Product NDC
25021-318
11-digit product format
250210318
Labeler code
25021
Product ID
25021-318_8a87ae13-88ca-49ae-bfd3-1ffb71cf9cbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adenosine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA206778
Marketing category
ANDA
Marketing start
2023-03-15
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
25021-318-02Adenosine10 in 1 CARTONINJECTION101
25021-318-02Adenosine2 mL in 1 VIALINJECTION21
25021-318-04Adenosine10 in 1 CARTONINJECTION101
25021-318-04Adenosine4 mL in 1 VIALINJECTION41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-318-02ML - Milliliter25021-31870d56e86-eace-456a-ad7c-72a790d031ad12023-05-05
25021-318-04ML - Milliliter25021-31868054f03-6b3f-47d8-9b20-8dcb9e68e97912023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-318ADENOSINE INJECTION [SAGENT PHARMACEUTICALS]1Current NDC, 4 package rows20230315_546642f2-662f-46cf-9d82-5bb3bdcc7677.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654169adenosine 6 MG in 2 ML InjectionPSN364a4c53-0705-7969-e063-6294a90a17173
1654169adenosine 6 MG in 2 ML InjectionPSN9508caf5-0e3a-4d32-909d-bff7ea40ec303
16541692 ML adenosine 3 MG/ML InjectionSCD364a4c53-0705-7969-e063-6294a90a17173
16541692 ML adenosine 3 MG/ML InjectionSCD9508caf5-0e3a-4d32-909d-bff7ea40ec303
1654169adenosine 6 MG per 2 ML InjectionSY364a4c53-0705-7969-e063-6294a90a17173
1654169adenosine 6 MG per 2 ML InjectionSY9508caf5-0e3a-4d32-909d-bff7ea40ec303
1654169adenosine 6 MG in 2 ML InjectionPSN296af833-5724-3e23-e063-6394a90a62511
1654169adenosine 6 MG in 2 ML InjectionPSN546642f2-662f-46cf-9d82-5bb3bdcc76771
16541692 ML adenosine 3 MG/ML InjectionSCD296af833-5724-3e23-e063-6394a90a62511
16541692 ML adenosine 3 MG/ML InjectionSCD546642f2-662f-46cf-9d82-5bb3bdcc76771
1654169adenosine 6 MG per 2 ML InjectionSY296af833-5724-3e23-e063-6394a90a62511
1654169adenosine 6 MG per 2 ML InjectionSY546642f2-662f-46cf-9d82-5bb3bdcc76771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-318-022502103180210 VIAL in 1 CARTON (25021-318-02) / 2 mL in 1 VIAL10 vial2023-03-15NoNoHistorical
25021-318-042502103180410 VIAL in 1 CARTON (25021-318-04) / 4 mL in 1 VIAL10 vial2023-03-15NoNoHistorical