FDA.reportPublic FDA data

ROPIVACAINE HYDROCHLORIDE

Product NDC
70512-798
11-digit product format
705120798
Labeler code
70512
Product ID
70512-798_45729174-5a1c-aa47-e063-6294a90af039
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
SOLA Pharmaceuticals, LLC
Application
ANDA212808
Marketing category
ANDA
Marketing start
2024-12-01
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
70512-798-01ROPIVACAINE HYDROCHLORIDE200 mL in 1 BAGINJECTION, SOLUTION2004
70512-798-24ROPIVACAINE HYDROCHLORIDE24 in 1 CARTONINJECTION, SOLUTION244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-798-01ML - Milliliter70512-798b5fcae5e-306b-46c4-a529-f3a05c3006df12025-05-14
70512-798-24ML - Milliliter70512-798764a1b54-b0c2-4fe8-9e27-51a09a86248212025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-798ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [SOLA PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20250330_5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSN5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a94
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSN5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a94
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a94
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a94
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSY5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a94
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSY5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a94
1734347ropivacaine HCl 200 MG per 100 ML InjectionSY5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a94
1734355ropivacaine HCl 400 MG per 200 ML InjectionSY5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70512-798-0170512079801200 mL in 1 BAG200 mlHistorical
70512-798-247051207982424 BAG in 1 CARTON (70512-798-24) / 200 mL in 1 BAG (70512-798-01) 24 bag2025-03-01NoNoHistorical