Ropivacaine Hydrochloride

Product NDC: 0143-9196
11-digit product format: 001439196
Labeler code: 0143
Product ID: 0143-9196_c4abd4d6-435c-4d2a-b670-717af36ceada
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ropivacaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; PERINEURAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA211907
Marketing category: ANDA
Marketing start: 2025-11-07
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: 2027-12-31
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	1734347, 1734355, 1734479

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
0143-9196-01	Ropivacaine Hydrochloride	200 mL in 1 BAG	INJECTION, SOLUTION	200		2
0143-9196-12	Ropivacaine Hydrochloride	12 in 1 CASE	INJECTION, SOLUTION	12		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9196-01	ML - Milliliter	0143-9196	a913a47e-10b2-4d21-bfd3-efcf75b00006	1	2025-12-16
0143-9196-12	ML - Milliliter	0143-9196	291a3d6d-921d-4d5e-a609-2fd5b6b752bc	1	2025-12-16

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
1734347	ROPivacaine HCl 0.2 % in 100 ML Injection	PSN	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734355	ROPivacaine HCl 0.2 % in 200 ML Injection	PSN	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734479	ROPivacaine HCl 0.5 % in 100 ML Injection	PSN	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734347	100 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734479	100 ML ropivacaine hydrochloride 5 MG/ML Injection	SCD	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734355	200 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734347	ropivacaine HCl 0.2 % per 100 ML Injection	SY	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734355	ropivacaine HCl 0.2 % per 200 ML Injection	SY	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734479	ropivacaine HCl 0.5 % per 100 ML Injection	SY	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734347	ropivacaine HCl 200 MG per 100 ML Injection	SY	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734355	ropivacaine HCl 400 MG per 200 ML Injection	SY	3d465e02-fd09-41b8-847f-bfe99cb4a712	2
1734479	ropivacaine HCl 500 MG per 100 ML Injection	SY	3d465e02-fd09-41b8-847f-bfe99cb4a712	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0143-9196-01	00143919601	200 mL in 1 BAG	200 ml				Historical
0143-9196-12	00143919612	12 BAG in 1 CASE (0143-9196-12) / 200 mL in 1 BAG (0143-9196-01)	12 bag	2025-11-07	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ropivacaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	2