FDA.reportPublic FDA data

ropivacaine hydrochloride

Product NDC
25021-671
11-digit product format
250210671
Labeler code
25021
Product ID
25021-671_22d83514-0f7b-4671-ae6a-7ca47449c184
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropivacaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION
Labeler
Sagent Pharmaceuticals
Application
ANDA206166
Marketing category
ANDA
Marketing start
2020-01-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ropivacaine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPIVACAINE HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV910P86109
Rxcui1734347, 1734355

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
25021-671-82ropivacaine hydrochloride100 mL in 1 BAGINJECTION, SOLUTION10011
25021-671-82ropivacaine hydrochloride10 in 1 CARTONINJECTION, SOLUTION1011
25021-671-87ropivacaine hydrochloride200 mL in 1 BAGINJECTION, SOLUTION20011
25021-671-87ropivacaine hydrochloride10 in 1 CARTONINJECTION, SOLUTION1011
25021-671-66ropivacaine hydrochloride100 mL in 1 BAGINJECTION, SOLUTION1005
25021-671-66ropivacaine hydrochloride10 in 1 CARTONINJECTION, SOLUTION105
25021-671-67ropivacaine hydrochloride10 in 1 CARTONINJECTION, SOLUTION105
25021-671-67ropivacaine hydrochloride200 mL in 1 BAGINJECTION, SOLUTION2005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-671-20ML - Milliliter25021-671a2b2c0f7-48eb-4b53-ac8f-51729b1edf0d12014-10-03
25021-671-66ML - Milliliter25021-671c1f1f50b-ed16-42f2-b8d8-4668ea825acf12020-05-08
25021-671-67ML - Milliliter25021-671ab43db9e-27e3-459e-a5bb-2cd4bf24495c12020-05-08
25021-671-82ML - Milliliter25021-67104e5efef-fcd2-4ca4-bfd8-dbecdf77def812019-02-13
25021-671-87ML - Milliliter25021-67193ffe764-6b68-4fd1-af54-eeba6bb4082412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-671ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]10Current NDC, Legacy NDC, 4 package rows20240328_8c5c762f-d266-4b1a-809e-f11bfc89bc2d.zip
25021-671ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]4Current NDC, Legacy NDC, 4 package rows20240328_9572b3de-684c-4028-a577-5aa69ba6b02d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSN8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSN8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734479ROPivacaine HCl 0.5 % in 100 ML InjectionPSN8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734481ROPivacaine HCl 0.5 % in 200 ML InjectionPSN8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734479100 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734481200 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSY8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSY8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734479ropivacaine HCl 0.5 % per 100 ML InjectionSY8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734481ropivacaine HCl 0.5 % per 200 ML InjectionSY8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734481ropivacaine HCl 1000 MG per 200 ML InjectionSY8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734347ropivacaine HCl 200 MG per 100 ML InjectionSY8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734355ropivacaine HCl 400 MG per 200 ML InjectionSY8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734479ropivacaine HCl 500 MG per 100 ML InjectionSY8c5c762f-d266-4b1a-809e-f11bfc89bc2d11
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSN9572b3de-684c-4028-a577-5aa69ba6b02d5
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSN9572b3de-684c-4028-a577-5aa69ba6b02d5
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD9572b3de-684c-4028-a577-5aa69ba6b02d5
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD9572b3de-684c-4028-a577-5aa69ba6b02d5
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSY9572b3de-684c-4028-a577-5aa69ba6b02d5
1734355ropivacaine HCl 0.2 % per 200 ML InjectionSY9572b3de-684c-4028-a577-5aa69ba6b02d5
1734347ropivacaine HCl 200 MG per 100 ML InjectionSY9572b3de-684c-4028-a577-5aa69ba6b02d5
1734355ropivacaine HCl 400 MG per 200 ML InjectionSY9572b3de-684c-4028-a577-5aa69ba6b02d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-671-662502106716610 BAG in 1 CARTON (25021-671-66) / 100 mL in 1 BAG10 bag2020-01-010000-00-00NoNoCurrent
25021-671-672502106716710 BAG in 1 CARTON (25021-671-67) / 200 mL in 1 BAG10 bag2020-01-010000-00-00NoNoCurrent
25021-671-822502106718210 BAG in 1 CARTON (25021-671-82) / 100 mL in 1 BAG10 bag2018-12-150000-00-00NoNoCurrent
25021-671-872502106718710 BAG in 1 CARTON (25021-671-87) / 200 mL in 1 BAG10 bag2018-12-150000-00-00NoNoCurrent