ROPIVACAINE HYDROCHLORIDE

Product NDC: 83854-014
11-digit product format: 838540014
Labeler code: 83854
Product ID: 83854-014_428b4218-2c8d-6dee-e063-6394a90a1b89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ROPIVACAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; PERINEURAL
Labeler: Anthea Pharma Private Limited
Application: ANDA219883
Marketing category: ANDA
Marketing start: 2025-03-21
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A219883-001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2025-03-21
A219883-002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2025-03-21
A219883-003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2025-03-21
A219883-004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	AP	2025-10-08
A219883-005	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2025-10-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A219883-001	AP
A219883-002	AP
A219883-003	AP
A219883-004	AP
A219883-005	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A219883-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219883-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219883-003	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219883-004	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	AP	2025-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219883-005	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2025-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219883-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219883-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219883-003	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219883-004	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	AP	2025-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219883-005	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2025-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219883-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219883-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219883-003	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219883-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219883-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219883-003	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2025-03-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219883-004	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	AP	2025-10-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219883-005	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2025-10-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A219883-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219883-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219883-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219883-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219883-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219883-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219883-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219883-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219883-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219883-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219883-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219883-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219883-003	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219883-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219883-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219883-003	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219883-004	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219883-005	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: ROPIVACAINE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V910P86109	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1734084	Internal RxNorm lookup
1734207	Internal RxNorm lookup
1734475	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f2b54355-a596-4f97-aeaa-d93e3984c42d	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
83854-014-01	ROPIVACAINE HYDROCHLORIDE	30 mL in 1 VIAL	INJECTION, SOLUTION	30	8
83854-014-02	ROPIVACAINE HYDROCHLORIDE	20 mL in 1 VIAL	INJECTION, SOLUTION	20	8
83854-014-05	ROPIVACAINE HYDROCHLORIDE	5 in 1 CARTON	INJECTION, SOLUTION	5	8
83854-014-06	ROPIVACAINE HYDROCHLORIDE	25 in 1 CARTON	INJECTION, SOLUTION	25	8
83854-014-10	ROPIVACAINE HYDROCHLORIDE	10 in 1 CARTON	INJECTION, SOLUTION	10	8
83854-014-25	ROPIVACAINE HYDROCHLORIDE	25 in 1 CARTON	INJECTION, SOLUTION	25	8
83854-014-26	ROPIVACAINE HYDROCHLORIDE	10 in 1 CARTON	INJECTION, SOLUTION	10	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83854-014	ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [ANTHEA PHARMA PRIVATE LIMITED]	4	Current NDC, 7 package rows	20250327_f2b54355-a596-4f97-aeaa-d93e3984c42d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	043b28cc-ce5c-4351-a646-704c381decb9	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219883 application number: ANDA219883
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	Anthea Pharma Private Limited	f2b54355-a596-4f97-aeaa-d93e3984c42d	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219883 application number: ANDA219883 ndc (product): 83854-014

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1734207	ROPivacaine HCl 0.2 % in 20 ML Injection	PSN	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734475	ROPivacaine HCl 0.5 % in 30 ML Injection	PSN	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734084	ROPivacaine HCl 1 % in 20 ML Injection	PSN	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734084	20 ML ropivacaine hydrochloride 10 MG/ML Injection	SCD	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734207	20 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734475	30 ML ropivacaine hydrochloride 5 MG/ML Injection	SCD	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734207	ropivacaine HCl 0.2 % per 20 ML Injection	SY	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734475	ropivacaine HCl 0.5 % per 30 ML Injection	SY	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734084	ropivacaine HCl 1 % per 20 ML Injection	SY	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734475	ropivacaine HCl 150 MG per 30 ML Injection	SY	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734084	ropivacaine HCl 200 MG per 20 ML Injection	SY	f2b54355-a596-4f97-aeaa-d93e3984c42d	8
1734207	ropivacaine HCl 40 MG per 20 ML Injection	SY	f2b54355-a596-4f97-aeaa-d93e3984c42d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83854-014-01	83854001401	30 mL in 1 VIAL	30 ml				Historical
83854-014-02	83854001402	20 mL in 1 VIAL	20 ml				Historical
83854-014-05	83854001405	5 VIAL in 1 CARTON (83854-014-05) / 30 mL in 1 VIAL (83854-014-01)	5 vial	2025-03-21	No	No	Current
83854-014-06	83854001406	25 VIAL in 1 CARTON (83854-014-06) / 30 mL in 1 VIAL (83854-014-01)	25 vial	2025-03-21	No	No	Current
83854-014-10	83854001410	10 VIAL in 1 CARTON (83854-014-10) / 30 mL in 1 VIAL (83854-014-01)	10 vial	2025-03-21	No	No	Current
83854-014-25	83854001425	25 VIAL in 1 CARTON (83854-014-25) / 20 mL in 1 VIAL (83854-014-02)	25 vial	2025-10-08	No	No	Current
83854-014-26	83854001426	10 VIAL in 1 CARTON (83854-014-26) / 20 mL in 1 VIAL (83854-014-02)	10 vial	2025-10-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROPIVACAINE HYDROCHLORIDE	Anthea Pharma Private Limited	2025-11-01	HUMAN PRESCRIPTION DRUG LABEL	8