FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
72603-216
11-digit product format
726030216
Labeler code
72603
Product ID
72603-216_61896fe6-4a5a-4e0f-bfc2-44265bc1f2c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
NorthStar Rx LLC
Application
ANDA212808
Marketing category
ANDA
Marketing start
2024-03-01
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
Rxcui1734084, 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
72603-216-01Ropivacaine Hydrochloride20 mL in 1 VIALINJECTION201
72603-216-25Ropivacaine Hydrochloride25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-216-01ML - Milliliter72603-216522d40a4-43d6-43a0-9bcd-62644d5fceab12024-05-16
72603-216-25ML - Milliliter72603-216c79f076a-d291-4d4f-aabb-d0abb22af3c612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-216ROPIVACAINE HYDROCHLORIDE INJECTION [NORTHSTAR RX LLC]1Current NDC, 2 package rows20240301_61896fe6-4a5a-4e0f-bfc2-44265bc1f2c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSN61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSN61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSN61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734483ropivacaine HCl 0.5 % per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734084ropivacaine HCl 1 % per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734483ropivacaine HCl 100 MG per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734084ropivacaine HCl 200 MG per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734207ropivacaine HCl 40 MG per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-216-017260302160120 mL in 1 VIAL20 mlHistorical
72603-216-257260302162525 VIAL in 1 CARTON (72603-216-25) / 20 mL in 1 VIAL (72603-216-01) 25 vial2024-03-01NoNoCurrent