FDA.reportPublic FDA data

ROPIVACAINE HYDROCHLORIDE

Product NDC
43066-154
11-digit product format
430660154
Labeler code
43066
Product ID
43066-154_fd79ad2e-1298-4643-bcb5-453b3bffe22a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION
Labeler
Baxter Healthcare Corporation
Application
ANDA210102
Marketing category
ANDA
Marketing start
2024-01-01
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
43066-154-01ROPIVACAINE HYDROCHLORIDE200 mL in 1 BAGINJECTION, SOLUTION2004
43066-154-10ROPIVACAINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43066-154ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]3Current NDC, 2 package rows20241220_e057aeb2-5125-490c-b691-847426fd42d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSNe057aeb2-5125-490c-b691-847426fd42d04
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSNe057aeb2-5125-490c-b691-847426fd42d04
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDe057aeb2-5125-490c-b691-847426fd42d04
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDe057aeb2-5125-490c-b691-847426fd42d04
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSYe057aeb2-5125-490c-b691-847426fd42d04
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSYe057aeb2-5125-490c-b691-847426fd42d04
1734347ropivacaine HCl 200 MG per 100 ML InjectionSYe057aeb2-5125-490c-b691-847426fd42d04
1734355ropivacaine HCl 400 MG per 200 ML InjectionSYe057aeb2-5125-490c-b691-847426fd42d04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43066-154-0143066015401200 mL in 1 BAG200 mlHistorical
43066-154-104306601541010 BAG in 1 CARTON (43066-154-10) / 200 mL in 1 BAG (43066-154-01) 10 bag2024-01-01NoNoCurrent