FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
70121-1733
11-digit product format
701211733
Labeler code
70121
Product ID
70121-1733_aa7176ac-f262-4470-a4de-60e288c05ac3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA216605
Marketing category
ANDA
Marketing start
2023-03-17
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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216605-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08
A216605-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08
A216605-003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07
A216605-004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A216605-001AP
A216605-002AP
A216605-003AP
A216605-004AP

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 3 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-0884e616aacf4f…
2026-09-14 22:38:342026-08A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-0884e616aacf4f…
2026-09-14 22:38:342026-08A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-0784e616aacf4f…
2026-09-14 22:38:342026-08A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-0784e616aacf4f…
2026-08-18 06:07:402026-07A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07caaa826d4ba7…
2026-08-18 06:07:402026-07A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-075bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216605-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A216605-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A216605-003AP184e616aacf4f…
2026-09-14 22:38:342026-08A216605-004AP184e616aacf4f…
2026-08-18 06:07:402026-07A216605-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A216605-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A216605-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A216605-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216605-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216605-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216605-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216605-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216605-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216605-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216605-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216605-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216605-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216605-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216605-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216605-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216605-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216605-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216605-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216605-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216605-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216605-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216605-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216605-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216605-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216605-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216605-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216605-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216605-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216605-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216605-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216605-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216605-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216605-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216605-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216605-004AP15bbf6a4d5a75…

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
1734347Internal RxNorm lookup
1734355Internal RxNorm lookup
1734479Internal RxNorm lookup
1734481Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
da1ce22b-6a8e-40a2-afbb-011fa3ed3a8bAvailable 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
70121-1733-3Ropivacaine Hydrochloride1 in 1 POUCHINJECTION112
70121-1733-3Ropivacaine Hydrochloride12 in 1 CARTONINJECTION1212
70121-1733-9Ropivacaine Hydrochloride1 in 1 POUCHINJECTION112
70121-1733-9Ropivacaine Hydrochloride24 in 1 CARTONINJECTION2412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1733-1ML - Milliliter70121-1733019293ca-e67a-49b5-b0ae-c95b7b5b4da512025-10-14
70121-1733-9ML - Milliliter70121-17338a3e4630-e4d9-4731-9c8f-7557edaedfdf12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1733ROPIVACAINE HYDROCHLORIDE INJECTION [AMNEAL PHARMACEUTICALS LLC]12Current NDC, 4 package rows20250309_da1ce22b-6a8e-40a2-afbb-011fa3ed3a8b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEAmneal Pharmaceuticals LLCda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b2024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216605
application number: ANDA216605
ndc (product): 70121-1733

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSNda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSNda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734479ROPivacaine HCl 0.5 % in 100 ML InjectionPSNda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734481ROPivacaine HCl 0.5 % in 200 ML InjectionPSNda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734479100 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCDda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734481200 ML ropivacaine hydrochloride 5 MG/ML InjectionSCDda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734479ropivacaine HCl 0.5 % per 100 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734481ropivacaine HCl 0.5 % per 200 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734481ropivacaine HCl 1000 MG per 200 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734347ropivacaine HCl 200 MG per 100 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734355ropivacaine HCl 400 MG per 200 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12
1734479ropivacaine HCl 500 MG per 100 ML InjectionSYda1ce22b-6a8e-40a2-afbb-011fa3ed3a8b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-1733-37012117330312 POUCH in 1 CARTON (70121-1733-3) / 1 BAG in 1 POUCH / 200 mL in 1 BAG12 pouch2023-12-04NoNoCurrent
70121-1733-97012117330924 POUCH in 1 CARTON (70121-1733-9) / 1 BAG in 1 POUCH / 200 mL in 1 BAG24 pouch2023-03-17NoNoCurrent