FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
17478-082
11-digit product format
174780082
Labeler code
17478
Product ID
17478-082_32112fae-3aee-4166-affc-595e6c6890cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Akorn
Application
ANDA204636
Marketing category
ANDA
Marketing start
2018-03-16
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
387afa15-cb51-403a-b2e2-1c9d201e07dcProduct name920230426

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-082-902024-01-30C16284748780-11030e365-0c9b-111a-e063-dadaa90a10e2Ropivacaine Hydrochloride Injection USP, 0.2%
17478-082-922024-01-30C16284748780-11030e365-0c9b-111a-e063-dadaa90a10e2Ropivacaine Hydrochloride Injection USP, 0.2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-082-90Ropivacaine Hydrochloride6 in 1 CARTONINJECTION, SOLUTION67
17478-082-90Ropivacaine Hydrochloride100 mL in 1 BOTTLEINJECTION, SOLUTION1007
17478-082-92Ropivacaine Hydrochloride6 in 1 CARTONINJECTION, SOLUTION67
17478-082-92Ropivacaine Hydrochloride200 mL in 1 BOTTLEINJECTION, SOLUTION2007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-082-90ML - Milliliter17478-0826f96e6e5-80bc-4a4a-982b-159f7d8db3fa12019-02-13
17478-082-92ML - Milliliter17478-0827fc894cd-de27-4f3f-bcd1-514a05dd8f7f12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-082ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AKORN]7Legacy NDC, 4 package rows20220916_3f538ea5-1e08-4fb5-9756-696ac3d817a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSN3f538ea5-1e08-4fb5-9756-696ac3d817a37
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSN3f538ea5-1e08-4fb5-9756-696ac3d817a37
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD3f538ea5-1e08-4fb5-9756-696ac3d817a37
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD3f538ea5-1e08-4fb5-9756-696ac3d817a37
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSY3f538ea5-1e08-4fb5-9756-696ac3d817a37
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSY3f538ea5-1e08-4fb5-9756-696ac3d817a37
1734347ropivacaine HCl 200 MG per 100 ML InjectionSY3f538ea5-1e08-4fb5-9756-696ac3d817a37
1734355ropivacaine HCl 400 MG per 200 ML InjectionSY3f538ea5-1e08-4fb5-9756-696ac3d817a37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-082-90174780082906 BOTTLE in 1 CARTON (17478-082-90) > 100 mL in 1 BOTTLE6 bottle2018-03-160000-00-00NoNoCurrent
17478-082-92174780082926 BOTTLE in 1 CARTON (17478-082-92) > 200 mL in 1 BOTTLE6 bottle2018-03-160000-00-00NoNoCurrent