ROPIVACAINE HYDROCHLORIDE

Product NDC: 43066-015
11-digit product format: 430660015
Labeler code: 43066
Product ID: 43066-015_a8d08579-825f-40d9-b1e3-e47b73765ae6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ropivacaine hydrochloride
Dosage form: INJECTION
Route: EPIDURAL; INFILTRATION; PERINEURAL
Labeler: Baxter Healthcare Corporation
Application: ANDA212808
Marketing category: ANDA
Marketing start: 2020-04-09
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#

Ingredient, Strength table
Ingredient	Strength
ROPIVACAINE HYDROCHLORIDE	2 mg/mL

Field, Values table
Field	Values
Unii	V910P86109
Rxcui	1734084, 1734207, 1734475, 1734483

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
387afa15-cb51-403a-b2e2-1c9d201e07dc	Product name	9	20230426

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43066-015-01	ROPIVACAINE HYDROCHLORIDE	20 mL in 1 VIAL	INJECTION	20		7
43066-015-10	ROPIVACAINE HYDROCHLORIDE	10 in 1 CARTON	INJECTION	10		7

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43066-015	ROPIVACAINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]	6	Current NDC, Legacy NDC, 2 package rows	20240922_781d4b7f-7556-4695-8d48-7772d7a0d8e9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V910P86109	ROPIVACAINE HYDROCHLORIDE	132112-35-7	ROPIVACAINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1734207	ROPivacaine HCl 0.2 % in 20 ML Injection	PSN	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734483	ROPivacaine HCl 0.5 % in 20 ML Injection	PSN	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734475	ROPivacaine HCl 0.5 % in 30 ML Injection	PSN	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734084	ROPivacaine HCl 1 % in 20 ML Injection	PSN	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734084	20 ML ropivacaine hydrochloride 10 MG/ML Injection	SCD	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734207	20 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734483	20 ML ropivacaine hydrochloride 5 MG/ML Injection	SCD	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734475	30 ML ropivacaine hydrochloride 5 MG/ML Injection	SCD	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734207	ropivacaine HCl 0.2 % per 20 ML Injection	SY	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734483	ropivacaine HCl 0.5 % per 20 ML Injection	SY	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734475	ropivacaine HCl 0.5 % per 30 ML Injection	SY	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734084	ropivacaine HCl 1 % per 20 ML Injection	SY	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734483	ropivacaine HCl 100 MG per 20 ML Injection	SY	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734475	ropivacaine HCl 150 MG per 30 ML Injection	SY	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734084	ropivacaine HCl 200 MG per 20 ML Injection	SY	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7
1734207	ropivacaine HCl 40 MG per 20 ML Injection	SY	781d4b7f-7556-4695-8d48-7772d7a0d8e9	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43066-015-01	43066001501	20 mL in 1 VIAL	20 ml					Historical
43066-015-10	43066001510	10 VIAL in 1 CARTON (43066-015-10) / 20 mL in 1 VIAL (43066-015-01)	10 vial	2020-04-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROPIVACAINE HYDROCHLORIDE	Baxter Healthcare Corporation	2023-06-28	HUMAN PRESCRIPTION DRUG LABEL	7