FDA.reportPublic FDA data

ROPIVACAINE HYDROCHLORIDE

Product NDC
67457-798
11-digit product format
674570798
Labeler code
67457
Product ID
67457-798_78b68980-9e8d-4f38-ba2a-a9d520451f5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Mylan Institutional LLC
Application
ANDA206091
Marketing category
ANDA
Marketing start
2024-03-18
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPIVACAINE HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV910P86109

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
67457-798-10ROPIVACAINE HYDROCHLORIDE100 mL in 1 BAGINJECTION, SOLUTION1001
67457-798-10ROPIVACAINE HYDROCHLORIDE1 in 1 POUCHINJECTION, SOLUTION11
67457-798-98ROPIVACAINE HYDROCHLORIDE24 in 1 CARTONINJECTION, SOLUTION241
67457-798-98ROPIVACAINE HYDROCHLORIDE1 in 1 POUCHINJECTION, SOLUTION11
67457-798-99ROPIVACAINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-798-10ML - Milliliter67457-798bfe51cc0-fe4a-4266-9b36-8c315ca2210f12024-04-05
67457-798-99ML - Milliliter67457-798ce666014-4d4e-4667-86f7-ac0686ac8a4912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-798ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]1Current NDC, 5 package rows20240322_9e1d1b15-c224-4ff4-a39d-3b9cebfc8403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSN9e1d1b15-c224-4ff4-a39d-3b9cebfc84031
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSN9e1d1b15-c224-4ff4-a39d-3b9cebfc84031
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD9e1d1b15-c224-4ff4-a39d-3b9cebfc84031
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD9e1d1b15-c224-4ff4-a39d-3b9cebfc84031
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSY9e1d1b15-c224-4ff4-a39d-3b9cebfc84031
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSY9e1d1b15-c224-4ff4-a39d-3b9cebfc84031
1734347ropivacaine HCl 200 MG per 100 ML InjectionSY9e1d1b15-c224-4ff4-a39d-3b9cebfc84031
1734355ropivacaine HCl 400 MG per 200 ML InjectionSY9e1d1b15-c224-4ff4-a39d-3b9cebfc84031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67457-798-1067457079810100 mL in 1 BAG100 mlHistorical
67457-798-986745707989824 in 1 CARTONHistorical
67457-798-996745707989910 POUCH in 1 CARTON (67457-798-99) / 1 BAG in 1 POUCH (67457-798-10) / 100 mL in 1 BAG10 pouch2024-03-18NoNoCurrent