FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
65219-632
11-digit product format
652190632
Labeler code
65219
Product ID
65219-632_7203f32f-2e48-4924-b882-d4f3863ae952
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
FRESENIUS KABI USA, LLC
Application
ANDA212808
Marketing category
ANDA
Marketing start
2024-12-10
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPIVACAINE HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV910P86109
Rxcui1734347, 1734355

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
387afa15-cb51-403a-b2e2-1c9d201e07dcProduct name920230426

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-632-02Ropivacaine Hydrochloride100 mL in 1 BAGINJECTION, SOLUTION1004
65219-632-04Ropivacaine Hydrochloride200 mL in 1 BAGINJECTION, SOLUTION2004
65219-632-10Ropivacaine Hydrochloride24 in 1 CASEINJECTION, SOLUTION244
65219-632-20Ropivacaine Hydrochloride24 in 1 CASEINJECTION, SOLUTION244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-632-02ML - Milliliter65219-632f6bf714b-1f70-4b81-9370-a52b825ece9412025-03-04
65219-632-04ML - Milliliter65219-63246a6b61d-65ef-46da-b3e2-7c3e7547f18512025-03-04
65219-632-10ML - Milliliter65219-63291c17563-87e5-4426-9bb5-e9331bf7f31a12025-03-04
65219-632-20ML - Milliliter65219-6328545928d-8652-4a3e-91b5-dbb29beac0cc12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-632ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]3Current NDC, 4 package rows20250205_da4a7675-97bf-4d2a-9fdc-c1b4b2999126.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSNda4a7675-97bf-4d2a-9fdc-c1b4b29991264
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSNda4a7675-97bf-4d2a-9fdc-c1b4b29991264
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDda4a7675-97bf-4d2a-9fdc-c1b4b29991264
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDda4a7675-97bf-4d2a-9fdc-c1b4b29991264
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSYda4a7675-97bf-4d2a-9fdc-c1b4b29991264
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSYda4a7675-97bf-4d2a-9fdc-c1b4b29991264
1734347ropivacaine HCl 200 MG per 100 ML InjectionSYda4a7675-97bf-4d2a-9fdc-c1b4b29991264
1734355ropivacaine HCl 400 MG per 200 ML InjectionSYda4a7675-97bf-4d2a-9fdc-c1b4b29991264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-632-0265219063202100 mL in 1 BAG100 mlHistorical
65219-632-0465219063204200 mL in 1 BAG200 mlHistorical
65219-632-106521906321024 BAG in 1 CASE (65219-632-10) / 100 mL in 1 BAG (65219-632-02) 24 bag2025-02-03NoNoHistorical
65219-632-206521906322024 BAG in 1 CASE (65219-632-20) / 200 mL in 1 BAG (65219-632-04) 24 bag2025-02-03NoNoHistorical