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FDA Approval

Adenosine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
NorthStar Rx LLC
DUNS: 830546433
Effective Date
July 12, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Adenosine(3 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Emcure Pharmaceuticals Limited

NorthStar Rx LLC

675467924

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Adenosine

Product Details

NDC Product Code
16714-556
Application Number
ANDA202313
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
July 12, 2022
AdenosineActive
Code: K72T3FS567Class: ACTIBQuantity: 3 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Adenosine

Product Details

NDC Product Code
16714-997
Application Number
ANDA202313
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
July 12, 2022
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
AdenosineActive
Code: K72T3FS567Class: ACTIBQuantity: 3 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

DRUG INTERACTIONS SECTION

Highlight: * Methylxanthines interfere with the activity of adenosine (7.1, 10)

  • Nucleoside transport inhibitors such as dipyridamole can increase the activity of adenosine (7.1)

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on Adenosine Injection

  • The vasoactive effects of adenosine are inhibited by adenosine receptor antagonists, (such as methylxanthines (e.g., caffeine, aminophylline, and theophylline). The safety and efficacy of adenosine injection in the presence of these agents has not been systematically evaluated [see Overdosage (10)].
  • The vasoactive effects of adenosine are potentiated by nucleoside transport inhibitors such as dipyridamole. The safety and efficacy of adenosine in the presence of dipyridamole has not been systematically evaluated.
  • Whenever possible, drugs that might inhibit or augment the effects of adenosine should be withheld for at least five half-lives prior to the use of adenosine injection.

7.2 Effects of Adenosine on Other Drugs

Adenosine injection has been given with other cardioactive drugs (such as beta adrenergic blocking agents, cardiac glycosides, and calcium channel blockers) without apparent adverse interactions, but its effectiveness with these agents has not been systematically evaluated. Because of the potential for additive or synergistic depressant effects on the SA and AV nodes, however, adenosine injection should be used with caution in the presence of these agents [see Warnings and Precautions (5.2)].


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