FDA.reportPublic FDA data

ropivacaine hydrochloride

Product NDC
25021-652
11-digit product format
250210652
Labeler code
25021
Product ID
25021-652_41f4446a-ca6e-465e-9a79-8c4f99eb1ac3
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
2019-07-15
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct25021-652DDiscontinued by firm2026-08-17
excluded packagepackage25021-65225021-652-30DDiscontinued by firm2026-08-17
excluded packagepackage25021-65225021-652-31DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage25021-652-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage25021-652-31d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage25021-652-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage25021-652-31f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage25021-652-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage25021-652-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage25021-652-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage25021-652-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage25021-652-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage25021-652-31cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage25021-652-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage25021-652-31cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage25021-652-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage25021-652-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage25021-652-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage25021-652-31ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage25021-652-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage25021-652-310efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage25021-652-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage25021-652-31ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage25021-652-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage25021-652-31367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage25021-652-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage25021-652-31557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206166-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11
A206166-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11
A206166-003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11
A206166-004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206166-001AP
A206166-002AP
A206166-003AP
A206166-004AP

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206166-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A206166-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A206166-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A206166-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206166-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206166-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206166-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206166-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206166-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206166-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206166-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206166-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206166-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206166-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206166-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206166-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206166-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206166-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206166-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206166-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206166-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206166-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206166-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206166-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206166-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206166-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206166-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206166-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206166-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206166-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206166-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206166-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206166-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206166-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206166-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206166-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206166-001ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206166-002ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206166-003ROPIVACAINE HYDROCHLORIDE500MG/100ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206166-004ROPIVACAINE HYDROCHLORIDE1GM/200ML (5MG/ML)SOLUTION / INJECTIONAP2018-06-11d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206166-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A206166-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A206166-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A206166-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206166-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206166-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206166-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206166-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206166-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206166-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206166-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206166-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206166-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206166-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206166-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206166-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206166-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206166-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206166-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206166-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206166-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206166-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206166-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206166-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206166-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206166-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206166-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206166-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206166-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206166-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206166-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206166-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206166-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206166-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206166-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206166-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206166-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206166-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206166-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206166-004AP1d8e5a09893c0…

Additional Listing Data#

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

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
8c5c762f-d266-4b1a-809e-f11bfc89bc2dAvailable 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
25021-652-82ropivacaine hydrochloride100 mL in 1 BAGINJECTION, SOLUTION10011
25021-652-82ropivacaine hydrochloride10 in 1 CARTONINJECTION, SOLUTION1011
25021-652-87ropivacaine hydrochloride10 in 1 CARTONINJECTION, SOLUTION1011
25021-652-87ropivacaine hydrochloride200 mL in 1 BAGINJECTION, SOLUTION20011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-652-30ML - Milliliter25021-65244936b9f-fecb-4282-bd5d-f23a84a774fc12014-10-03
25021-652-31ML - Milliliter25021-652e8470a70-fd6b-4177-b2fe-34f5bc66ce7a12014-10-03
25021-652-82ML - Milliliter25021-65233e5fa18-2a0d-4a9c-ba3b-58a0d387f2e712019-09-05
25021-652-87ML - Milliliter25021-652a710efb1-2ae8-4fe1-a00f-3244ebcc096412019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-652ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]10Current NDC, Legacy NDC, 4 package rows20240328_8c5c762f-d266-4b1a-809e-f11bfc89bc2d.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ropivacaine hydrochlorideROPIVACAINE HYDROCHLORIDESagent Pharmaceuticals9572b3de-684c-4028-a577-5aa69ba6b02d2025-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206166
application number: ANDA206166
ropivacaine hydrochlorideROPIVACAINE HYDROCHLORIDESagent Pharmaceuticals8c5c762f-d266-4b1a-809e-f11bfc89bc2d2025-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206166
application number: ANDA206166
ndc (product): 25021-652

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-652-822502106528210 BAG in 1 CARTON (25021-652-82) / 100 mL in 1 BAG10 bag2019-07-150000-00-00NoNoCurrent
25021-652-872502106528710 BAG in 1 CARTON (25021-652-87) / 200 mL in 1 BAG10 bag2019-07-150000-00-00NoNoCurrent