FDA.reportPublic FDA data

ROPIVACAINE HYDROCHLORIDE

Product NDC
83854-014
11-digit product format
838540014
Labeler code
83854
Product ID
83854-014_428b4218-2c8d-6dee-e063-6394a90a1b89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Anthea Pharma Private Limited
Application
ANDA219883
Marketing category
ANDA
Marketing start
2025-03-21
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, 1734475

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
83854-014-01ROPIVACAINE HYDROCHLORIDE30 mL in 1 VIALINJECTION, SOLUTION308
83854-014-02ROPIVACAINE HYDROCHLORIDE20 mL in 1 VIALINJECTION, SOLUTION208
83854-014-05ROPIVACAINE HYDROCHLORIDE5 in 1 CARTONINJECTION, SOLUTION58
83854-014-06ROPIVACAINE HYDROCHLORIDE25 in 1 CARTONINJECTION, SOLUTION258
83854-014-10ROPIVACAINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION108
83854-014-25ROPIVACAINE HYDROCHLORIDE25 in 1 CARTONINJECTION, SOLUTION258
83854-014-26ROPIVACAINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83854-014ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [ANTHEA PHARMA PRIVATE LIMITED]4Current NDC, 7 package rows20250327_f2b54355-a596-4f97-aeaa-d93e3984c42d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSNf2b54355-a596-4f97-aeaa-d93e3984c42d8
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSNf2b54355-a596-4f97-aeaa-d93e3984c42d8
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSNf2b54355-a596-4f97-aeaa-d93e3984c42d8
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCDf2b54355-a596-4f97-aeaa-d93e3984c42d8
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDf2b54355-a596-4f97-aeaa-d93e3984c42d8
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDf2b54355-a596-4f97-aeaa-d93e3984c42d8
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSYf2b54355-a596-4f97-aeaa-d93e3984c42d8
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSYf2b54355-a596-4f97-aeaa-d93e3984c42d8
1734084ropivacaine HCl 1 % per 20 ML InjectionSYf2b54355-a596-4f97-aeaa-d93e3984c42d8
1734475ropivacaine HCl 150 MG per 30 ML InjectionSYf2b54355-a596-4f97-aeaa-d93e3984c42d8
1734084ropivacaine HCl 200 MG per 20 ML InjectionSYf2b54355-a596-4f97-aeaa-d93e3984c42d8
1734207ropivacaine HCl 40 MG per 20 ML InjectionSYf2b54355-a596-4f97-aeaa-d93e3984c42d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83854-014-018385400140130 mL in 1 VIAL30 mlHistorical
83854-014-028385400140220 mL in 1 VIAL20 mlHistorical
83854-014-05838540014055 VIAL in 1 CARTON (83854-014-05) / 30 mL in 1 VIAL (83854-014-01) 5 vial2025-03-21NoNoCurrent
83854-014-068385400140625 VIAL in 1 CARTON (83854-014-06) / 30 mL in 1 VIAL (83854-014-01) 25 vial2025-03-21NoNoCurrent
83854-014-108385400141010 VIAL in 1 CARTON (83854-014-10) / 30 mL in 1 VIAL (83854-014-01) 10 vial2025-03-21NoNoCurrent
83854-014-258385400142525 VIAL in 1 CARTON (83854-014-25) / 20 mL in 1 VIAL (83854-014-02) 25 vial2025-10-08NoNoCurrent
83854-014-268385400142610 VIAL in 1 CARTON (83854-014-26) / 20 mL in 1 VIAL (83854-014-02) 10 vial2025-10-08NoNoCurrent