FDA.reportPublic FDA data

ROPIVACAINE HYDROCHLORIDE

Product NDC
68462-777
11-digit product format
684620777
Labeler code
68462
Product ID
68462-777_94b5c770-9085-490d-a39c-5c9f8c659118
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA219883
Marketing category
ANDA
Marketing start
2025-10-08
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
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219883-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2025-03-21
A219883-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2025-03-21
A219883-003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2025-03-21
A219883-004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2025-10-08
A219883-005ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2025-10-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A219883-001AP
A219883-002AP
A219883-003AP
A219883-004AP
A219883-005AP

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 22:54:322026-06A219883-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2025-03-21a50c72e98297…
2026-08-01 22:54:322026-06A219883-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2025-03-21a50c72e98297…
2026-08-01 22:54:322026-06A219883-003ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2025-03-21a50c72e98297…
2026-08-01 22:54:322026-06A219883-004ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2025-10-08a50c72e98297…
2026-08-01 22:54:322026-06A219883-005ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2025-10-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A219883-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A219883-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A219883-003AP1a50c72e98297…
2026-08-01 22:54:322026-06A219883-004AP1a50c72e98297…
2026-08-01 22:54:322026-06A219883-005AP1a50c72e98297…

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 HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA043b28cc-ce5c-4351-a646-704c381decb92026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219883
application number: ANDA219883
ndc (product): 68462-777
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDEAnthea Pharma Private Limitedf2b54355-a596-4f97-aeaa-d93e3984c42d2025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219883
application number: ANDA219883

Additional Listing Data#

Finished product
Yes
Brand name base
ROPIVACAINE HYDROCHLORIDE
Listing expiration
2027-12-31

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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1734084Internal RxNorm lookup
1734203Internal RxNorm lookup
1734207Internal 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
043b28cc-ce5c-4351-a646-704c381decb9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
387afa15-cb51-403a-b2e2-1c9d201e07dcProduct name920230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-777-10ROPIVACAINE HYDROCHLORIDE10 mL in 1 VIALINJECTION, SOLUTION103
68462-777-35ROPIVACAINE HYDROCHLORIDE25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-777-10ML - Milliliter68462-777f1909d2f-a0af-4c1a-a05b-904e3fb3e28512026-01-08
68462-777-35ML - Milliliter68462-7778788f69a-abfc-4c5e-8bde-92312809dd7c12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734203ROPivacaine HCl 0.2 % in 10 ML InjectionPSN043b28cc-ce5c-4351-a646-704c381decb93
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSN043b28cc-ce5c-4351-a646-704c381decb93
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSN043b28cc-ce5c-4351-a646-704c381decb93
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN043b28cc-ce5c-4351-a646-704c381decb93
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSN043b28cc-ce5c-4351-a646-704c381decb93
173420310 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD043b28cc-ce5c-4351-a646-704c381decb93
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD043b28cc-ce5c-4351-a646-704c381decb93
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD043b28cc-ce5c-4351-a646-704c381decb93
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD043b28cc-ce5c-4351-a646-704c381decb93
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD043b28cc-ce5c-4351-a646-704c381decb93
1734203ropivacaine HCl 0.2 % per 10 ML InjectionSY043b28cc-ce5c-4351-a646-704c381decb93
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSY043b28cc-ce5c-4351-a646-704c381decb93
1734483ropivacaine HCl 0.5 % per 20 ML InjectionSY043b28cc-ce5c-4351-a646-704c381decb93
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY043b28cc-ce5c-4351-a646-704c381decb93
1734084ropivacaine HCl 1 % per 20 ML InjectionSY043b28cc-ce5c-4351-a646-704c381decb93
1734483ropivacaine HCl 100 MG per 20 ML InjectionSY043b28cc-ce5c-4351-a646-704c381decb93
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY043b28cc-ce5c-4351-a646-704c381decb93
1734203ropivacaine HCl 20 MG per 10 ML InjectionSY043b28cc-ce5c-4351-a646-704c381decb93
1734084ropivacaine HCl 200 MG per 20 ML InjectionSY043b28cc-ce5c-4351-a646-704c381decb93
1734207ropivacaine HCl 40 MG per 20 ML InjectionSY043b28cc-ce5c-4351-a646-704c381decb93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-777-106846207771010 mL in 1 VIAL10 mlHistorical
68462-777-356846207773525 VIAL in 1 CARTON (68462-777-35) / 10 mL in 1 VIAL (68462-777-10) 25 vial2025-10-08NoNoCurrent