Ropivacaine Hydrochloride

Product NDC
0409-9301
11-digit product format
004099301
Labeler code
0409
Product ID
0409-9301_0669f092-f34e-40c2-af54-8004c205032d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Hospira, Inc.
Application
ANDA090194
Marketing category
ANDA
Marketing start
2014-09-23
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-9301DDiscontinued by firm2026-08-17
excluded packagepackage0409-93010409-9301-30DDiscontinued 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 · 24 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 packagepackage0409-9301-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-9301-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-9301-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-9301-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-9301-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-9301-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-9301-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-9301-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-9301-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-9301-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-9301-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-9301-30557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090194-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTION2014-09-23
A090194-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTION2014-09-23
A090194-003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTION2014-09-23
A090194-004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTION2014-09-23
A090194-005ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTION2014-09-23
A090194-006ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTION2014-09-23

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 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090194-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTION2014-09-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090194-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTION2014-09-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090194-003ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTION2014-09-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090194-004ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTION2014-09-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090194-005ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTION2014-09-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090194-006ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTION2014-09-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090194-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTION2014-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090194-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTION2014-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090194-003ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTION2014-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090194-004ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTION2014-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090194-005ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTION2014-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090194-006ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTION2014-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090194-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTION2014-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090194-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTION2014-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090194-003ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTION2014-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090194-004ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTION2014-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090194-005ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTION2014-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090194-006ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTION2014-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090194-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTION2014-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090194-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTION2014-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090194-003ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTION2014-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090194-004ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTION2014-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090194-005ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTION2014-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090194-006ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTION2014-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090194-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTION2014-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090194-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTION2014-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090194-003ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTION2014-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090194-004ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTION2014-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090194-005ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTION2014-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090194-006ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTION2014-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090194-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTION2014-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090194-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTION2014-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090194-003ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTION2014-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090194-004ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTION2014-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090194-005ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTION2014-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090194-006ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTION2014-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090194-001ROPIVACAINE HYDROCHLORIDE20MG/10ML (2MG/ML)SOLUTION / INJECTION2014-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090194-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTION2014-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090194-003ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTION2014-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090194-004ROPIVACAINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INJECTION2014-09-2303ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A090194-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090194-002AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090194-003AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090194-004AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090194-005AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090194-006AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090194-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090194-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090194-003AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090194-004AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090194-005AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090194-006AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090194-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090194-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090194-003AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090194-004AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090194-005AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090194-006AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090194-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090194-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090194-003AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090194-004AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090194-005AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090194-006AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090194-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090194-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090194-003AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090194-004AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090194-005AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090194-006AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090194-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090194-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090194-003AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090194-004AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090194-005AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090194-006AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090194-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090194-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090194-003AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090194-004AP1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-9301-30ML - Milliliter0409-930109097616-1376-42ad-9dfb-f029ec8ca3cc12014-11-05
0409-9301-31ML - Milliliter0409-93010ccf081d-4100-484c-b7f0-aab36f8a277112014-11-05

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-9301-300040993013010 VIAL, SINGLE-DOSE in 1 CARTON (0409-9301-30) > 30 mL in 1 VIAL, SINGLE-DOSE (0409-9301-31) 2014-09-230000-00-00NoNoCurrent