Ropivacaine Hydrochloride

Product NDC
72603-219
11-digit product format
726030219
Labeler code
72603
Product ID
72603-219_61896fe6-4a5a-4e0f-bfc2-44265bc1f2c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL
Labeler
NorthStar Rx LLC
Application
ANDA212808
Marketing category
ANDA
Marketing start
2024-03-01
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
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72603-219DDiscontinued by firm2026-08-17
excluded packagepackage72603-21972603-219-25DDiscontinued by firm2026-08-17

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…

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
72603-219-01Ropivacaine Hydrochloride20 mL in 1 VIALINJECTION201
72603-219-25Ropivacaine Hydrochloride25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-219-01ML - Milliliter72603-219e019e789-e813-42a1-9e82-fb669034a58912024-05-16
72603-219-25ML - Milliliter72603-219038186af-38d8-4325-b138-c1939af0bac912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-219ROPIVACAINE HYDROCHLORIDE INJECTION [NORTHSTAR RX LLC]1Current NDC, 2 package rows20240301_61896fe6-4a5a-4e0f-bfc2-44265bc1f2c1.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
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
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSN61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSN61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSN61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734483ropivacaine HCl 0.5 % per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734084ropivacaine HCl 1 % per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734483ropivacaine HCl 100 MG per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734084ropivacaine HCl 200 MG per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11
1734207ropivacaine HCl 40 MG per 20 ML InjectionSY61896fe6-4a5a-4e0f-bfc2-44265bc1f2c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-219-017260302190120 mL in 1 VIAL20 mlHistorical
72603-219-257260302192525 VIAL in 1 CARTON (72603-219-25) / 20 mL in 1 VIAL (72603-219-01) 25 vial2024-03-01NoNoHistorical