FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
70121-1734
11-digit product format
701211734
Labeler code
70121
Product ID
70121-1734_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
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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A216605-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08a50c72e98297…
2026-08-01 22:54:322026-06A216605-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2023-03-08a50c72e98297…
2026-08-01 22:54:322026-06A216605-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07a50c72e98297…
2026-08-01 22:54:322026-06A216605-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2023-03-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216605-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A216605-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A216605-003AP1a50c72e98297…
2026-08-01 22:54:322026-06A216605-004AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 70121-1734

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 · 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
70121-1734-3Ropivacaine Hydrochloride12 in 1 CARTONINJECTION1212
70121-1734-3Ropivacaine Hydrochloride1 in 1 POUCHINJECTION112
70121-1734-7Ropivacaine Hydrochloride10 in 1 CARTONINJECTION1012
70121-1734-7Ropivacaine Hydrochloride1 in 1 POUCHINJECTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1734-1ML - Milliliter70121-1734c247961d-0c62-41ce-9791-30b24f76b16212025-10-14
70121-1734-3ML - Milliliter70121-17343dacabc4-fa70-4f5f-98d8-724b443463a912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1734ROPIVACAINE HYDROCHLORIDE INJECTION [AMNEAL PHARMACEUTICALS LLC]12Current NDC, 4 package rows20250309_da1ce22b-6a8e-40a2-afbb-011fa3ed3a8b.zip

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
70121-1734-37012117340312 POUCH in 1 CARTON (70121-1734-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG12 pouch2023-12-04NoNoCurrent
70121-1734-77012117340710 POUCH in 1 CARTON (70121-1734-7) / 1 BAG in 1 POUCH / 100 mL in 1 BAG10 pouch2023-03-17NoNoCurrent