FDA.reportPublic FDA data

Remifentanil Hydrochloride

Product NDC
63323-724
11-digit product format
633230724
Labeler code
63323
Product ID
63323-724_2f27e51f-2b55-47ee-bd4a-001b71c60622
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Remifentanil Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA206223
Marketing category
ANDA
Marketing start
2018-01-19
Substance
REMIFENTANIL HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Remifentanil Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
REMIFENTANIL HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5V444H5WIC
Rxcui1729578, 1729584, 1729710

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
672afe0b-f5cc-4f09-b505-57eb5a9ce437Product name220210513
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-724-01Remifentanil Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,56
63323-724-05Remifentanil Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-724-01EA - Each63323-724d5600837-9989-48b4-9119-545845fbab4012018-02-20
63323-724-05EA - Each63323-7242aa3c995-9514-4604-9650-17ffcec1760212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-724REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20241027_d2374b84-81c9-44f9-a4a9-1071281b2531.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1729578remifentanil 1 MG InjectionPSNd2374b84-81c9-44f9-a4a9-1071281b25316
1729584remifentanil 2 MG InjectionPSNd2374b84-81c9-44f9-a4a9-1071281b25316
1729710remifentanil 5 MG InjectionPSNd2374b84-81c9-44f9-a4a9-1071281b25316
1729578remifentanil 1 MG InjectionSCDd2374b84-81c9-44f9-a4a9-1071281b25316
1729584remifentanil 2 MG InjectionSCDd2374b84-81c9-44f9-a4a9-1071281b25316
1729710remifentanil 5 MG InjectionSCDd2374b84-81c9-44f9-a4a9-1071281b25316
1729578remifentanil (as remifentanil hydrochloride) 1 MG InjectionSYd2374b84-81c9-44f9-a4a9-1071281b25316
1729584remifentanil (as remifentanil hydrochloride) 2 MG InjectionSYd2374b84-81c9-44f9-a4a9-1071281b25316
1729710remifentanil (as remifentanil hydrochloride) 5 MG InjectionSYd2374b84-81c9-44f9-a4a9-1071281b25316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-724-01633230724015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
63323-724-056332307240510 VIAL, SINGLE-DOSE in 1 CARTON (63323-724-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-724-01) 2018-01-190000-00-00NoNoCurrent