FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
70069-064
11-digit product format
700690064
Labeler code
70069
Product ID
70069-064_79b226f0-c08a-4f84-bf2b-ae5c60e01d67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Somerset Therapeutics, LLC
Application
ANDA207636
Marketing category
ANDA
Marketing start
2018-06-15
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
Rxcui905189, 1734084, 1734090, 1734203, 1734207, 1734475, 1734483

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
70069-064-01Ropivacaine Hydrochloride30 mL in 1 VIALINJECTION3013
70069-064-01Ropivacaine Hydrochloride1 in 1 CARTONINJECTION113
70069-064-10Ropivacaine Hydrochloride30 mL in 1 VIALINJECTION3013
70069-064-10Ropivacaine Hydrochloride10 in 1 CARTONINJECTION1013
70069-064-25Ropivacaine Hydrochloride30 mL in 1 VIALINJECTION3013
70069-064-25Ropivacaine Hydrochloride25 in 1 CARTONINJECTION2513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-064-01ML - Milliliter70069-064ae602216-08bd-4cfc-932f-d7e7ba8d573f12018-08-13
70069-064-10ML - Milliliter70069-0648dc3f0f7-4865-4215-8504-b911f982785412022-02-07
70069-064-25ML - Milliliter70069-064acb44a68-90b0-4efe-b264-c0bce853581912022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-064ROPIVACAINE HYDROCHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC]12Current NDC, Legacy NDC, 6 package rows20221110_ffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734203ROPivacaine HCl 0.2 % in 10 ML InjectionPSNffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSNffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSNffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSNffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
905189ROPivacaine HCl 0.75 % in 20 ML InjectionPSNffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734090ROPivacaine HCl 1 % in 10 ML InjectionPSNffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSNffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
173409010 ML ropivacaine hydrochloride 10 MG/ML InjectionSCDffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
173420310 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCDffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
90518920 ML ropivacaine hydrochloride 7.5 MG/ML InjectionSCDffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734203ropivacaine HCl 0.2 % per 10 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734483ropivacaine HCl 0.5 % per 20 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
905189ropivacaine HCl 0.75 % per 20 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734090ropivacaine HCl 1 % per 10 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734084ropivacaine HCl 1 % per 20 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734090ropivacaine HCl 100 MG per 10 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734483ropivacaine HCl 100 MG per 20 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
905189ropivacaine HCl 150 MG per 20 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734475ropivacaine HCl 150 MG per 30 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734203ropivacaine HCl 20 MG per 10 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734084ropivacaine HCl 200 MG per 20 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734207ropivacaine HCl 40 MG per 20 ML InjectionSYffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe6413
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN56b664ad-03e0-4bf3-8efa-40ce3e8d34982
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN3f793f80-57da-1599-e063-6394a90a1dab2
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD3f793f80-57da-1599-e063-6394a90a1dab2
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD56b664ad-03e0-4bf3-8efa-40ce3e8d34982
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY3f793f80-57da-1599-e063-6394a90a1dab2
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY56b664ad-03e0-4bf3-8efa-40ce3e8d34982
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY56b664ad-03e0-4bf3-8efa-40ce3e8d34982
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY3f793f80-57da-1599-e063-6394a90a1dab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-064-01700690064011 VIAL in 1 CARTON (70069-064-01) / 30 mL in 1 VIAL1 vial2018-06-150000-00-00NoNoCurrent
70069-064-107006900641010 VIAL in 1 CARTON (70069-064-10) / 30 mL in 1 VIAL10 vial2021-12-200000-00-00NoNoCurrent
70069-064-257006900642525 VIAL in 1 CARTON (70069-064-25) / 30 mL in 1 VIAL25 vial2021-12-200000-00-00NoNoCurrent