Home NDC 55150-197 Ropivacaine Hydrochloride
Product NDC 55150-197
11-digit product format 551500197
Labeler code 55150
Product ID 55150-197_1e5f1368-058a-492c-b4b7-d9329a7745e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ropivacaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; PERINEURAL
Labeler Eugia US LLC
Application ANDA205612
Marketing category ANDA
Marketing start 2016-09-15
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205612-001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 A205612-002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 A205612-003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 A205612-004 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 A205612-005 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2016-07-13 A205612-006 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 A205612-007 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 matching rows.
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.
Product history page 1 of 8 · 294 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A205612-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205612-002 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205612-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205612-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205612-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2016-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205612-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205612-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205612-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205612-002 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205612-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205612-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205612-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2016-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205612-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205612-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205612-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205612-002 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205612-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205612-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205612-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2016-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205612-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205612-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205612-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205612-002 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205612-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205612-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205612-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2016-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205612-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205612-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205612-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205612-002 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205612-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205612-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205612-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2016-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205612-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205612-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205612-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205612-002 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205612-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205612-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205612-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2016-07-13 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 294 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ropivacaine Hydrochloride
Listing expiration 2027-12-31 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 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905189 Internal RxNorm lookup 1734084 Internal RxNorm lookup 1734090 Internal RxNorm lookup 1734207 Internal RxNorm lookup 1734347 Internal RxNorm lookup 1734475 Internal RxNorm lookup 1734483 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55150-197-20 Ropivacaine Hydrochloride 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 10 55150-197-20 Ropivacaine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 10 55150-197-20 Ropidex 25 in 1 CARTON INJECTION, SOLUTION 5 mg in 1mL 4 55150-197-20 Ropidex 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 mL 5 mg in 1mL 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-197 ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC] 8 Current NDC, Legacy NDC, 2 package rows 20230804_3763b7b6-da49-4658-b93d-28f5da24d09e.zip 55150-197 ROPIDEX (DEXAMETHASONE SODIUM PHOSPHATE, ROPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 4 Current NDC, Legacy NDC 20241008_2577c1ba-8aff-4098-ba11-a375e9ce3caa.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55150-197-20 55150019720 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-197-20) / 20 mL in 1 VIAL, SINGLE-DOSE 2016-09-15 0000-00-00 No No Current