FDA.reportPublic FDA data

NDC 70069-062-01 - Ropivacaine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70069-062
Requested NDC
70069-062-01
Package NDCs from labels
70069-062-01, 70069-062-25, 70069-062-10
Manufacturer
Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited
Effective date
2025-10-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ROPIVACAINE - Somerset Therapeutics, LLC | Somerset Therapeutics Private LimitedSomerset Therapeutics, LLC | Somerset Therapeutics Private Limited2025-10-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-062-01Ropivacaine Hydrochloride20 mL in 1 VIALINJECTION2013
70069-062-10Ropivacaine Hydrochloride10 in 1 CARTONINJECTION1013
70069-062-25Ropivacaine Hydrochloride25 in 1 CARTONINJECTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-062ROPIVACAINE HYDROCHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC]12Current NDC, Legacy NDC, 3 package rows20221110_ffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe64.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-062-01ML - Milliliter70069-0628966ad39-bdfb-4029-abbd-8cbd27baa99212023-01-09
70069-062-10ML - Milliliter70069-062f3fd160a-8159-427e-be1b-56b2506471af12023-01-09
70069-062-25ML - Milliliter70069-062bdd8051e-75ed-4a4a-95d3-63dd3e45c9d412023-01-09

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 19 of 54 · 1,074 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Care SalineSODIUM CHLORIDEUnited Exchange Corp.06737393-d4ae-3e7b-e063-6394a90ac19f2025-10-31WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.009bef3c-e8ac-46be-b564-a2556adf00812025-10-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEICU Medical Inc.237b39fa-916e-4a54-99c8-4ae9ad54f0562025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.0e089a44-0cee-4804-8f6f-8508508ddb5c2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.189b8ac6-e346-454f-b501-7645590ca4f82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cold and Cough 4 KidsONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.e06599ca-fc94-4b2c-829e-f3d4ec866ed62025-10-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC97007188-43fe-416c-a87b-6ccc4d9ae2ec2025-10-29Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Lactated Ringers and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporation05f326e6-10e4-4ceb-8a23-f53c592f00b82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Corporation6acc9f96-7088-45a7-b48f-1a861e3467ab2025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDEBaxter Healthcare Companydad7735c-709b-40ea-ab7a-15577e24a9662025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
unii: 451W47IQ8X
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDESomerset Therapeutics, LLCffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe642025-10-25Warnings, Adverse reactionsExact identifier
application number: ANDA207636
ndc (package): 70069-064-01
ndc (package): 70069-065-25
ndc (package): 70069-062-25
ndc (package): 70069-067-10
ndc (package): 70069-066-01
ndc (package): 70069-066-10
ndc (package): 70069-065-01
ndc (package): 70069-067-25
ndc (package): 70069-063-25
ndc (package): 70069-062-10
ndc (package): 70069-064-25
ndc (package): 70069-063-01
ndc (package): 70069-061-10
ndc (package): 70069-061-01
ndc (package): 70069-066-25
ndc (package): 70069-061-25
ndc (package): 70069-067-01
ndc (package): 70069-064-10
ndc (package): 70069-062-01
ndc (product): 70069-063
ndc (product): 70069-067
ndc (product): 70069-062
ndc (product): 70069-064
ndc (product): 70069-061
ndc (product): 70069-066
ndc (product): 70069-065
ndc11 (package): 70069006201
rxcui: 1734090
rxcui: 1734203
rxcui: 1734483
rxcui: 1734207
rxcui: 1734475
rxcui: 1734084
rxcui: 905189
spl id: 79b226f0-c08a-4f84-bf2b-ae5c60e01d67
spl set id: ffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe64
unii: V910P86109
Jacksons Cell Salts KALI MUR 6X 5KALI MURIATICUMZettl Health Inc.41ed34d0-94c3-ce79-e063-6294a90a08cb2025-10-24WarningsExact identifier
unii: 451W47IQ8X
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
miranda castros HEALING FOR INSECT BITES AND STINGSCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENSMIRANDA CASTRO'S SHOP, LLC1f99d32e-2394-411a-e063-6294a90ac4542025-10-23WarningsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.b96eb740-749a-4d3a-ae63-b8e3947cad302025-10-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.