FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
85766-098
11-digit product format
857660098
Labeler code
85766
Product ID
85766-098_503911bf-380c-d5f2-e063-6294a90ac760
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Sportpharm LLC
Application
ANDA205612
Marketing category
ANDA
Marketing start
2016-09-15
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ropivacaine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV910P86109
Rxcui1734475

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
85766-098-01Ropivacaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION303
85766-098-01Ropivacaine Hydrochloride1 in 1 CARTONINJECTION, SOLUTION13
85766-098-25Ropivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION253
85766-098-25Ropivacaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION303
85766-098-30Ropivacaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION303
85766-098-30Ropivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN7327766c-19f0-4d83-89c6-eb685e0d286c3
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD7327766c-19f0-4d83-89c6-eb685e0d286c3
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY7327766c-19f0-4d83-89c6-eb685e0d286c3
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY7327766c-19f0-4d83-89c6-eb685e0d286c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-098-01857660098011 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-01) / 30 mL in 1 VIAL, SINGLE-DOSE2025-10-15NoNoCurrent
85766-098-258576600982525 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-25) / 30 mL in 1 VIAL, SINGLE-DOSE2025-10-15NoNoCurrent
85766-098-308576600983030 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical