Ropivacaine Hydrochloride

Product NDC
84549-164
11-digit product format
845490164
Labeler code
84549
Product ID
84549-164_463f04e3-2619-2343-e063-6394a90a6ae4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
ProPharma Distribution
Application
ANDA207636
Marketing category
ANDA
Marketing start
2018-06-15
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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207636-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-15
A207636-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-15
A207636-003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-15
A207636-004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-15
A207636-005ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2018-06-15
A207636-006ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-15
A207636-007ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A207636-001AP
A207636-002AP
A207636-003AP
A207636-004AP
A207636-005AP
A207636-006AP
A207636-007AP

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 8 · 294 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207636-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-002ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2018-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207636-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-002ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2018-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-002ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2018-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207636-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-002ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2018-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-002ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2018-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-006ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-007ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2018-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207636-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207636-002ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207636-003ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207636-004ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207636-005ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTIONAP2018-06-15b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207636-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-006AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207636-007AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207636-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207636-007AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-006AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207636-007AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207636-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-006AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207636-007AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-006AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207636-007AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207636-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207636-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207636-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207636-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207636-005AP1b8a1b40f171c…

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
3f793f80-57da-1599-e063-6394a90a1dabAvailable 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
84549-164-25Ropivacaine Hydrochloride30 mL in 1 VIALINJECTION302

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDESportpharm LLC56b664ad-03e0-4bf3-8efa-40ce3e8d34982026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207636
application number: ANDA207636
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEProPharma Distribution3f793f80-57da-1599-e063-6394a90a1dab2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207636
application number: ANDA207636
ndc (product): 84549-164
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDESomerset Therapeutics, LLCffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe642025-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207636
application number: ANDA207636

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN3f793f80-57da-1599-e063-6394a90a1dab2
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD3f793f80-57da-1599-e063-6394a90a1dab2
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY3f793f80-57da-1599-e063-6394a90a1dab2
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY3f793f80-57da-1599-e063-6394a90a1dab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-164-258454901642530 mL in 1 VIAL (84549-164-25) 30 ml2025-10-10NoNoCurrent