FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
70518-2681
Requested package NDC
70518-2681-0
11-digit product format
705182681
Labeler code
70518
Product ID
70518-2681_dc8b1619-388c-02d2-e053-2995a90af8ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
REMEDYREPACK INC.
Application
ANDA205612
Marketing category
ANDA
Marketing start
2020-04-08
Marketing end
0000-00-00
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-268170518-2681-0DDiscontinued by firm2026-07-31

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2681-07051826810025 VIAL, SINGLE-DOSE in 1 CARTON (70518-2681-0) > 20 mL in 1 VIAL, SINGLE-DOSE (70518-2681-1) 2020-04-080000-00-00NoNoCurrent