FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
70121-1735
11-digit product format
701211735
Labeler code
70121
Product ID
70121-1735_aa7176ac-f262-4470-a4de-60e288c05ac3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA216605
Marketing category
ANDA
Marketing start
2023-03-17
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
Rxcui1734347, 1734355, 1734479, 1734481

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
70121-1735-3Ropivacaine Hydrochloride1 in 1 POUCHINJECTION112
70121-1735-3Ropivacaine Hydrochloride12 in 1 CARTONINJECTION1212
70121-1735-7Ropivacaine Hydrochloride1 in 1 POUCHINJECTION112
70121-1735-7Ropivacaine Hydrochloride10 in 1 CARTONINJECTION1012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1735ROPIVACAINE HYDROCHLORIDE INJECTION [AMNEAL PHARMACEUTICALS LLC]12Current NDC, 4 package rows20250309_da1ce22b-6a8e-40a2-afbb-011fa3ed3a8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSNda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSNda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734479ROPivacaine HCl 0.5 % in 100 ML InjectionPSNda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734481ROPivacaine HCl 0.5 % in 200 ML InjectionPSNda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734479100 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734481200 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734479ropivacaine HCl 0.5 % per 100 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734481ropivacaine HCl 0.5 % per 200 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734481ropivacaine HCl 1000 MG per 200 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734347ropivacaine HCl 200 MG per 100 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734355ropivacaine HCl 400 MG per 200 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734479ropivacaine HCl 500 MG per 100 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-1735-37012117350312 POUCH in 1 CARTON (70121-1735-3) / 1 BAG in 1 POUCH / 200 mL in 1 BAG12 pouch2023-12-04NoNoHistorical
70121-1735-77012117350710 POUCH in 1 CARTON (70121-1735-7) / 1 BAG in 1 POUCH / 200 mL in 1 BAG10 pouch2023-03-17NoNoHistorical