Ropivacaine Hydrochloride

Product NDC: 84549-164
11-digit product format: 845490164
Labeler code: 84549
Product ID: 84549-164_463f04e3-2619-2343-e063-6394a90a6ae4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ropivacaine Hydrochloride
Dosage form: INJECTION
Route: EPIDURAL; INFILTRATION; PERINEURAL
Labeler: ProPharma Distribution
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#

Ingredient, Strength table
Ingredient	Strength
ROPIVACAINE HYDROCHLORIDE	5 mg/mL

Field, Values table
Field	Values
Unii	V910P86109
Rxcui	1734475

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
84549-164-25	Ropivacaine Hydrochloride	30 mL in 1 VIAL	INJECTION	30		2

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
1734475	ROPivacaine HCl 0.5 % in 30 ML Injection	PSN	3f793f80-57da-1599-e063-6394a90a1dab	2
1734475	30 ML ropivacaine hydrochloride 5 MG/ML Injection	SCD	3f793f80-57da-1599-e063-6394a90a1dab	2
1734475	ropivacaine HCl 0.5 % per 30 ML Injection	SY	3f793f80-57da-1599-e063-6394a90a1dab	2
1734475	ropivacaine HCl 150 MG per 30 ML Injection	SY	3f793f80-57da-1599-e063-6394a90a1dab	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-164-25	84549016425	30 mL in 1 VIAL (84549-164-25)	30 ml	2025-10-10	No	No	Historical