ROPIVACAINE HYDROCHLORIDE

Product NDC
43066-015
11-digit product format
430660015
Labeler code
43066
Product ID
43066-015_a8d08579-825f-40d9-b1e3-e47b73765ae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropivacaine hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Baxter Healthcare Corporation
Application
ANDA212808
Marketing category
ANDA
Marketing start
2020-04-09
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 · 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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-092680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-005AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-006AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-004AP12680178bc6a6…

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1734084Internal 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
781d4b7f-7556-4695-8d48-7772d7a0d8e9Available 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
43066-015-01ROPIVACAINE HYDROCHLORIDE20 mL in 1 VIALINJECTION207
43066-015-10ROPIVACAINE HYDROCHLORIDE10 in 1 CARTONINJECTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43066-015ROPIVACAINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]6Current NDC, Legacy NDC, 2 package rows20240922_781d4b7f-7556-4695-8d48-7772d7a0d8e9.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 · 7 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
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDENorthStar Rx LLC61896fe6-4a5a-4e0f-bfc2-44265bc1f2c12024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDEBaxter Healthcare Corporation781d4b7f-7556-4695-8d48-7772d7a0d8e92023-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
ndc (product): 43066-015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSN781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSN781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSN781d4b7f-7556-4695-8d48-7772d7a0d8e97
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD781d4b7f-7556-4695-8d48-7772d7a0d8e97
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD781d4b7f-7556-4695-8d48-7772d7a0d8e97
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD781d4b7f-7556-4695-8d48-7772d7a0d8e97
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSY781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734483ropivacaine HCl 0.5 % per 20 ML InjectionSY781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734084ropivacaine HCl 1 % per 20 ML InjectionSY781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734483ropivacaine HCl 100 MG per 20 ML InjectionSY781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734084ropivacaine HCl 200 MG per 20 ML InjectionSY781d4b7f-7556-4695-8d48-7772d7a0d8e97
1734207ropivacaine HCl 40 MG per 20 ML InjectionSY781d4b7f-7556-4695-8d48-7772d7a0d8e97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43066-015-014306600150120 mL in 1 VIAL20 mlHistorical
43066-015-104306600151010 VIAL in 1 CARTON (43066-015-10) / 20 mL in 1 VIAL (43066-015-01) 10 vial2020-04-090000-00-00NoNoCurrent