Ropivacaine Hydrochloride

Product NDC
72572-707
11-digit product format
725720707
Labeler code
72572
Product ID
72572-707_4827eb8a-a1a0-404d-b468-241473a80918
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Civica, Inc.
Application
ANDA212808
Marketing category
ANDA
Marketing start
2022-09-19
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
Rxcui1734475

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
387afa15-cb51-403a-b2e2-1c9d201e07dcProduct name920230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-707-01Ropivacaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION304
72572-707-10Ropivacaine Hydrochloride10 in 1 CARTONINJECTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-707-01ML - Milliliter72572-707966e3038-d057-48be-8086-7a2bdee459d612022-11-07
72572-707-10ML - Milliliter72572-7075620e768-a3ee-48a0-a8e3-da2833b2e72412022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-707ROPIVACAINE HYDROCHLORIDE INJECTION [CIVICA, INC.]4Current NDC, Legacy NDC, 2 package rows20241109_1fb8e90a-4141-4707-8be6-31f2da5c8fd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN1fb8e90a-4141-4707-8be6-31f2da5c8fd54
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD1fb8e90a-4141-4707-8be6-31f2da5c8fd54
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY1fb8e90a-4141-4707-8be6-31f2da5c8fd54
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY1fb8e90a-4141-4707-8be6-31f2da5c8fd54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-707-017257207070130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
72572-707-107257207071010 VIAL, SINGLE-DOSE in 1 CARTON (72572-707-10) / 30 mL in 1 VIAL, SINGLE-DOSE (72572-707-01) 2022-09-190000-00-00NoNoCurrent