MKO Melt Dose Pack

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

Company

DUNS: 080431967

Effective Date

March 4, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Midazolam(3 mg in 1 1)

Ketamine(25 mg in 1 1)

Ondansetron(2 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

DUNS Number

080431967

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

NDC Product Code

71384-410

Route of Administration

SUBLINGUAL

Effective Date

March 4, 2019

Ingredients

Code: R60L0SM5BCClass: ACTIBQuantity: 3 mg in 1 1

Code: O18YUO0I83Class: ACTIMQuantity: 25 mg in 1 1

Code: 2999F27MADClass: ACTIMQuantity: 2 mg in 1 1

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

Store at 20° to 25° C (68° to 77° F)

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