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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage85766-09885766-098-30DDiscontinued by firm2026-10-05

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage85766-09885766-098-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205612-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-13
A205612-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-13
A205612-003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-13
A205612-004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-13
A205612-005ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2016-07-13
A205612-006ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-13
A205612-007ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A205612-001AP
A205612-002AP
A205612-003AP
A205612-004AP
A205612-005AP
A205612-006AP
A205612-007AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205612-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A205612-002ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A205612-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A205612-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A205612-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A205612-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A205612-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-1384e616aacf4f…
2026-08-18 06:07:402026-07A205612-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-002ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205612-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-002ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-002ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A205612-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-002ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205612-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205612-002ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205612-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205612-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205612-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2016-07-13fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205612-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A205612-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A205612-003AP184e616aacf4f…
2026-09-14 22:38:342026-08A205612-004AP184e616aacf4f…
2026-09-14 22:38:342026-08A205612-005AP184e616aacf4f…
2026-09-14 22:38:342026-08A205612-006AP184e616aacf4f…
2026-09-14 22:38:342026-08A205612-007AP184e616aacf4f…
2026-08-18 06:07:402026-07A205612-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-006AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A205612-007AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205612-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205612-007AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-006AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205612-007AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205612-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-006AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205612-007AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205612-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205612-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205612-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205612-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205612-005AP1fd3edfee7708…

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
IngredientStrength
ROPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V910P86109Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1734475Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7327766c-19f0-4d83-89c6-eb685e0d286cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
387afa15-cb51-403a-b2e2-1c9d201e07dcProduct name920230426

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-098-01Ropivacaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION303
85766-098-01Ropivacaine Hydrochloride1 in 1 CARTONINJECTION, SOLUTION13
85766-098-25Ropivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION253
85766-098-25Ropivacaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION303
85766-098-30Ropivacaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION303
85766-098-30Ropivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION253

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDESportpharm LLC7327766c-19f0-4d83-89c6-eb685e0d286c2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205612
application number: ANDA205612
ndc (product): 85766-098
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEEugia US LLC3763b7b6-da49-4658-b93d-28f5da24d09e2026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205612
application number: ANDA205612

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN7327766c-19f0-4d83-89c6-eb685e0d286c3
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD7327766c-19f0-4d83-89c6-eb685e0d286c3
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY7327766c-19f0-4d83-89c6-eb685e0d286c3
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY7327766c-19f0-4d83-89c6-eb685e0d286c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-098-01857660098011 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-01) / 30 mL in 1 VIAL, SINGLE-DOSE2025-10-15NoNoCurrent
85766-098-258576600982525 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-25) / 30 mL in 1 VIAL, SINGLE-DOSE2025-10-15NoNoCurrent
85766-098-308576600983030 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical