FDA.reportPublic FDA data

Ropivacaine hydrochloride

Product NDC
68083-262
11-digit product format
680830262
Labeler code
68083
Product ID
68083-262_59ffca85-dbbf-49c1-8516-027b9de5f396
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION
Labeler
Gland Pharma Limited
Application
ANDA210102
Marketing category
ANDA
Marketing start
2022-08-18
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
2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210102-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2022-08-18
A210102-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2022-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210102-001AP
A210102-002AP

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 22:54:322026-06A210102-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2022-08-18a50c72e98297…
2026-08-01 22:54:322026-06A210102-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2022-08-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210102-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A210102-002AP1a50c72e98297…

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 HYDROCHLORIDEBaxter Healthcare Corporatione057aeb2-5125-490c-b691-847426fd42d02023-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210102
application number: ANDA210102
Ropivacaine hydrochlorideROPIVACAINE HYDROCHLORIDEGland Pharma Limited643c1729-096e-459c-80c1-78b78e698da62022-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210102
application number: ANDA210102
ndc (product): 68083-262

Additional Listing Data#

Finished product
Yes
Brand name base
Ropivacaine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPIVACAINE HYDROCHLORIDE2 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1734347Internal RxNorm lookup
1734355Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
643c1729-096e-459c-80c1-78b78e698da6Available 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
68083-262-01Ropivacaine hydrochloride100 mL in 1 BAGINJECTION, SOLUTION1006
68083-262-01Ropivacaine hydrochloride1 in 1 POUCHINJECTION, SOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-262ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]6Current NDC, Legacy NDC, 2 package rows20220824_643c1729-096e-459c-80c1-78b78e698da6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSN643c1729-096e-459c-80c1-78b78e698da66
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSN643c1729-096e-459c-80c1-78b78e698da66
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD643c1729-096e-459c-80c1-78b78e698da66
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD643c1729-096e-459c-80c1-78b78e698da66
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSY643c1729-096e-459c-80c1-78b78e698da66
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSY643c1729-096e-459c-80c1-78b78e698da66
1734347ropivacaine HCl 200 MG per 100 ML InjectionSY643c1729-096e-459c-80c1-78b78e698da66
1734355ropivacaine HCl 400 MG per 200 ML InjectionSY643c1729-096e-459c-80c1-78b78e698da66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-262-01680830262011 BAG in 1 POUCH (68083-262-01) / 100 mL in 1 BAG1 bag2022-08-180000-00-00NoNoCurrent