FDA.reportPublic FDA data

ROPIVACAINE HYDROCHLORIDE

Product NDC
68462-795
11-digit product format
684620795
Labeler code
68462
Product ID
68462-795_94b5c770-9085-490d-a39c-5c9f8c659118
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA219883
Marketing category
ANDA
Marketing start
2025-08-07
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 42.

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
2026-08-18 06:07:402026-07A219883-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2025-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A219883-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2025-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A219883-003ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2025-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A219883-004ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2025-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A219883-005ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2025-10-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219883-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2025-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219883-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2025-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219883-003ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2025-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219883-004ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2025-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219883-005ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2025-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219883-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2025-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219883-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2025-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219883-003ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2025-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219883-004ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2025-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219883-005ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2025-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A219883-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2025-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219883-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2025-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219883-003ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2025-03-216a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219883-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2025-03-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219883-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2025-03-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219883-003ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2025-03-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219883-004ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2025-10-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219883-005ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2025-10-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219883-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219883-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219883-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219883-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219883-005AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219883-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219883-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219883-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219883-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219883-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219883-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219883-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219883-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219883-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219883-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219883-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219883-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219883-003AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219883-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219883-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219883-003AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219883-004AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219883-005AP1a50c72e98297…

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 · 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
68462-795-20ROPIVACAINE HYDROCHLORIDE20 mL in 1 VIALINJECTION, SOLUTION203
68462-795-55ROPIVACAINE HYDROCHLORIDE25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-795-20ML - Milliliter68462-795cace828f-14e7-4550-bcf3-f47006788eb412025-12-16
68462-795-55ML - Milliliter68462-795e2b54245-c4c3-4d82-ba4f-7085ee721b7412025-12-16

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 HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA043b28cc-ce5c-4351-a646-704c381decb92026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219883
application number: ANDA219883
ndc (product): 68462-795
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDEAnthea Pharma Private Limitedf2b54355-a596-4f97-aeaa-d93e3984c42d2025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219883
application number: ANDA219883

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
68462-795-206846207952020 mL in 1 VIAL20 mlHistorical
68462-795-556846207955525 VIAL in 1 CARTON (68462-795-55) / 20 mL in 1 VIAL (68462-795-20) 25 vial2025-08-07NoNoCurrent