FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
67457-876
11-digit product format
674570876
Labeler code
67457
Product ID
67457-876_7006cce5-a917-4f4d-9620-1933ef256a87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropivacaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Mylan Institutional LLC
Application
ANDA090318
Marketing category
ANDA
Marketing start
2019-05-23
Marketing end
2021-03-31
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
150 mg/30mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67457-876DDiscontinued by firm2026-07-31
excluded packagepackage67457-87667457-876-30DDiscontinued by firm2026-07-31
excluded packagepackage67457-87667457-876-99DDiscontinued by firm2026-07-31

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
A090318-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTION2014-09-23
A090318-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTION2014-09-23
A090318-003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTION2014-09-23
A090318-004ROPIVACAINE 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090318-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTION2014-09-23a50c72e98297…
2026-08-01 22:54:322026-06A090318-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTION2014-09-23a50c72e98297…
2026-08-01 22:54:322026-06A090318-003ROPIVACAINE HYDROCHLORIDE150MG/20ML (7.5MG/ML)SOLUTION / INJECTION2014-09-23a50c72e98297…
2026-08-01 22:54:322026-06A090318-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTION2014-09-23a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-876-30ML - Milliliter67457-876b21af171-cc0a-4f32-b5a2-3829395ceedf12019-06-19
67457-876-99ML - Milliliter67457-8764f7234d6-1f24-4bf0-b96b-04d18e360ed412022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-876-30674570876301 VIAL in 1 CARTON (67457-876-30) > 30 mL in 1 VIAL1 vial2019-05-232021-03-31NoNoCurrent
67457-876-99674570876995 VIAL in 1 CARTON (67457-876-99) > 30 mL in 1 VIAL5 vial2019-05-232021-03-31NoNoCurrent