FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
71288-735
11-digit product format
712880735
Labeler code
71288
Product ID
71288-735_f5ce6fdb-2cd1-4ebf-a884-541b2976534f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA218713
Marketing category
ANDA
Marketing start
2024-07-30
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
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 HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV910P86109
Rxcui905189, 1734084, 1734090, 1734203, 1734207, 1734475, 1734483

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
71288-735-30Ropivacaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION303
71288-735-31Ropivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-735-30ML - Milliliter71288-735a8acd0f4-306a-4074-bedb-9e3e0eb1b8c412024-11-05
71288-735-31ML - Milliliter71288-7353eee7723-6ad7-4c99-a17a-bf4839067fc712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-735ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, 2 package rows20240906_d00bfdee-d3e9-4faf-b079-43ac1add51b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734203ROPivacaine HCl 0.2 % in 10 ML InjectionPSNd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSNd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSNd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSNd00bfdee-d3e9-4faf-b079-43ac1add51b33
905189ROPivacaine HCl 0.75 % in 20 ML InjectionPSNd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734090ROPivacaine HCl 1 % in 10 ML InjectionPSNd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSNd00bfdee-d3e9-4faf-b079-43ac1add51b33
173409010 ML ropivacaine hydrochloride 10 MG/ML InjectionSCDd00bfdee-d3e9-4faf-b079-43ac1add51b33
173420310 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDd00bfdee-d3e9-4faf-b079-43ac1add51b33
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCDd00bfdee-d3e9-4faf-b079-43ac1add51b33
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDd00bfdee-d3e9-4faf-b079-43ac1add51b33
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDd00bfdee-d3e9-4faf-b079-43ac1add51b33
90518920 ML ropivacaine hydrochloride 7.5 MG/ML InjectionSCDd00bfdee-d3e9-4faf-b079-43ac1add51b33
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734203ropivacaine HCl 0.2 % per 10 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734483ropivacaine HCl 0.5 % per 20 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
905189ropivacaine HCl 0.75 % per 20 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734090ropivacaine HCl 1 % per 10 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734084ropivacaine HCl 1 % per 20 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734090ropivacaine HCl 100 MG per 10 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734483ropivacaine HCl 100 MG per 20 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
905189ropivacaine HCl 150 MG per 20 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734475ropivacaine HCl 150 MG per 30 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734203ropivacaine HCl 20 MG per 10 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734084ropivacaine HCl 200 MG per 20 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33
1734207ropivacaine HCl 40 MG per 20 ML InjectionSYd00bfdee-d3e9-4faf-b079-43ac1add51b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-735-307128807353030 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
71288-735-317128807353125 VIAL, SINGLE-DOSE in 1 CARTON (71288-735-31) / 30 mL in 1 VIAL, SINGLE-DOSE (71288-735-30) 2024-07-30NoNoHistorical