FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
55150-200
11-digit product format
551500200
Labeler code
55150
Product ID
55150-200_1e5f1368-058a-492c-b4b7-d9329a7745e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL
Labeler
Eugia US LLC
Application
ANDA205612
Marketing category
ANDA
Marketing start
2016-09-15
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
10 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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A205612-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-13a50c72e98297…
2026-08-01 22:54:322026-06A205612-002ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2016-07-13a50c72e98297…
2026-08-01 22:54:322026-06A205612-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-13a50c72e98297…
2026-08-01 22:54:322026-06A205612-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-07-13a50c72e98297…
2026-08-01 22:54:322026-06A205612-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2016-07-13a50c72e98297…
2026-08-01 22:54:322026-06A205612-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-13a50c72e98297…
2026-08-01 22:54:322026-06A205612-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2016-07-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205612-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A205612-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A205612-003AP1a50c72e98297…
2026-08-01 22:54:322026-06A205612-004AP1a50c72e98297…
2026-08-01 22:54:322026-06A205612-005AP1a50c72e98297…
2026-08-01 22:54:322026-06A205612-006AP1a50c72e98297…
2026-08-01 22:54:322026-06A205612-007AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEEugia US LLC3763b7b6-da49-4658-b93d-28f5da24d09e2026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205612
application number: ANDA205612
ndc (product): 55150-200

Additional Listing Data#

Finished product
Yes
Brand name base
Ropivacaine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPIVACAINE HYDROCHLORIDE10 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 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
905189Internal RxNorm lookup
1734084Internal RxNorm lookup
1734090Internal RxNorm lookup
1734207Internal RxNorm lookup
1734347Internal RxNorm lookup
1734475Internal RxNorm lookup
1734483Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3763b7b6-da49-4658-b93d-28f5da24d09eAvailable 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
55150-200-10Ropivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION2510
55150-200-10Ropivacaine Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-200-10ML - Milliliter55150-200b710637f-aaa4-41f8-b46d-b9f4f7682ff812016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-200ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]8Current NDC, Legacy NDC, 2 package rows20230804_3763b7b6-da49-4658-b93d-28f5da24d09e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
905189ROPivacaine HCl 0.75 % in 20 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
1734090ROPivacaine HCl 1 % in 10 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
173409010 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
90518920 ML ropivacaine hydrochloride 7.5 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734483ropivacaine HCl 0.5 % per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
905189ropivacaine HCl 0.75 % per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734090ropivacaine HCl 1 % per 10 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734084ropivacaine HCl 1 % per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734090ropivacaine HCl 100 MG per 10 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734483ropivacaine HCl 100 MG per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
905189ropivacaine HCl 150 MG per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734347ropivacaine HCl 200 MG per 100 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734084ropivacaine HCl 200 MG per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734207ropivacaine HCl 40 MG per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-200-105515002001025 VIAL, SINGLE-DOSE in 1 CARTON (55150-200-10) / 10 mL in 1 VIAL, SINGLE-DOSE2016-09-150000-00-00NoNoCurrent