Home NDC 85766-098 Ropivacaine Hydrochloride
Product NDC 85766-098
11-digit product format 857660098
Labeler code 85766
Product ID 85766-098_503911bf-380c-d5f2-e063-6294a90ac760
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ropivacaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; PERINEURAL
Labeler Sportpharm 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
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 85766-098 85766-098-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 301 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 2026-09-14 22:38:34 2026-08 A205612-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205612-002 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2016-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205612-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205612-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2016-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205612-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2016-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205612-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205612-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2016-07-13 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 301 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1734475 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 85766-098-01 Ropivacaine Hydrochloride 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 3 85766-098-01 Ropivacaine Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 3 85766-098-25 Ropivacaine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 3 85766-098-25 Ropivacaine Hydrochloride 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 3 85766-098-30 Ropivacaine Hydrochloride 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 3 85766-098-30 Ropivacaine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 3
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 Units Marketing start Sample Exclude flag Status 85766-098-01 85766009801 1 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-01) / 30 mL in 1 VIAL, SINGLE-DOSE 2025-10-15 No No Current 85766-098-25 85766009825 25 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-25) / 30 mL in 1 VIAL, SINGLE-DOSE 2025-10-15 No No Current 85766-098-30 85766009830 30 mL in 1 VIAL, SINGLE-DOSE 30 ml Historical