Ropivacaine Hydrochloride

Product NDC
72572-707
11-digit product format
725720707
Labeler code
72572
Product ID
72572-707_4827eb8a-a1a0-404d-b468-241473a80918
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Civica, Inc.
Application
ANDA212808
Marketing category
ANDA
Marketing start
2022-09-19
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
5 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 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212808-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-09
A212808-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09
A212808-003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09
A212808-004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-09
A212808-005ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23
A212808-006ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A212808-001AP
A212808-002AP
A212808-003AP
A212808-004AP
A212808-005AP
A212808-006AP

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.

Product history page 1 of 5 · 182 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-0903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 182 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212808-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A212808-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A212808-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A212808-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A212808-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A212808-006AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212808-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-006AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-006AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212808-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-006AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-006AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-005AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-006AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-004AP103ed91905a0d…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPIVACAINE HYDROCHLORIDE5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1734475Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1fb8e90a-4141-4707-8be6-31f2da5c8fd5Available 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
72572-707-01Ropivacaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION304
72572-707-10Ropivacaine Hydrochloride10 in 1 CARTONINJECTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-707-01ML - Milliliter72572-707966e3038-d057-48be-8086-7a2bdee459d612022-11-07
72572-707-10ML - Milliliter72572-7075620e768-a3ee-48a0-a8e3-da2833b2e72412022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-707ROPIVACAINE HYDROCHLORIDE INJECTION [CIVICA, INC.]4Current NDC, Legacy NDC, 2 package rows20241109_1fb8e90a-4141-4707-8be6-31f2da5c8fd5.zip

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEArmas Pharmaceuticals Inc.3849f5ce-d077-4318-935d-294be69481422026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLA Pharmaceuticals, LLC5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a92025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEFRESENIUS KABI USA, LLCda4a7675-97bf-4d2a-9fdc-c1b4b29991262025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDECaplin Steriles Limiteda9010ea8-0923-44e4-a7c7-7d65d37d06db2025-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDECivica, Inc.1fb8e90a-4141-4707-8be6-31f2da5c8fd52024-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
ndc (product): 72572-707
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDEBaxter Healthcare Corporation781d4b7f-7556-4695-8d48-7772d7a0d8e92023-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN1fb8e90a-4141-4707-8be6-31f2da5c8fd54
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD1fb8e90a-4141-4707-8be6-31f2da5c8fd54
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY1fb8e90a-4141-4707-8be6-31f2da5c8fd54
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY1fb8e90a-4141-4707-8be6-31f2da5c8fd54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-707-017257207070130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
72572-707-107257207071010 VIAL, SINGLE-DOSE in 1 CARTON (72572-707-10) / 30 mL in 1 VIAL, SINGLE-DOSE (72572-707-01) 2022-09-190000-00-00NoNoCurrent