FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
65145-109
11-digit product format
651450109
Labeler code
65145
Product ID
65145-109_2d5d4dcd-b082-4bbb-838b-615d0f14bbc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Caplin Steriles Limited
Application
ANDA212808
Marketing category
ANDA
Marketing start
2025-06-24
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
Rxcui1734084, 1734207, 1734347, 1734355, 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
65145-109-01Ropivacaine Hydrochloride30 mL in 1 VIALINJECTION308
65145-109-10Ropivacaine Hydrochloride10 in 1 CARTONINJECTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-109-01ML - Milliliter65145-109e1ebe3d3-4355-434b-8db1-eea0eeb1be3712024-10-04
65145-109-10ML - Milliliter65145-10931e80d71-c487-4acd-b359-7fac2188038a12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-109ROPIVACAINE HYDROCHLORIDE INJECTION [CAPLIN STERILES LIMITED]7Current NDC, Legacy NDC, 2 package rows20250130_a9010ea8-0923-44e4-a7c7-7d65d37d06db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSNa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSNa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSNa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSNa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSNa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSNa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDa9010ea8-0923-44e4-a7c7-7d65d37d06db8
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCDa9010ea8-0923-44e4-a7c7-7d65d37d06db8
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDa9010ea8-0923-44e4-a7c7-7d65d37d06db8
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDa9010ea8-0923-44e4-a7c7-7d65d37d06db8
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734483ropivacaine HCl 0.5 % per 20 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734084ropivacaine HCl 1 % per 20 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734483ropivacaine HCl 100 MG per 20 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734475ropivacaine HCl 150 MG per 30 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734347ropivacaine HCl 200 MG per 100 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734084ropivacaine HCl 200 MG per 20 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734207ropivacaine HCl 40 MG per 20 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8
1734355ropivacaine HCl 400 MG per 200 ML InjectionSYa9010ea8-0923-44e4-a7c7-7d65d37d06db8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65145-109-016514501090130 mL in 1 VIAL30 mlHistorical
65145-109-106514501091010 VIAL in 1 CARTON (65145-109-10) / 30 mL in 1 VIAL (65145-109-01) 10 vial2025-06-240000-00-00NoNoCurrent