Home NDC 0143-9265 Ropivacaine Hydrochloride
Product NDC 0143-9265
11-digit product format 001439265
Labeler code 0143
Product ID 0143-9265_ca74bdef-8c1f-4919-a7e9-a7655953b3af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ropivacaine Hydrochloride
Dosage form INJECTION
Route EPIDURAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA214074
Marketing category ANDA
Marketing start 2025-11-18
Substance ROPIVACAINE HYDROCHLORIDE
Active strength 7.5 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214074-001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 A214074-002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 A214074-003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 A214074-004 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 4 · 156 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A214074-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214074-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214074-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214074-004 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214074-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214074-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214074-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214074-004 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214074-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214074-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214074-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214074-004 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214074-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214074-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214074-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214074-004 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214074-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214074-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214074-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214074-004 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214074-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214074-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214074-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214074-004 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214074-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214074-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214074-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214074-004 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214074-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214074-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214074-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214074-004 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214074-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214074-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214074-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214074-004 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214074-001 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2020-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214074-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2020-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214074-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2020-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214074-004 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2020-07-20 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 156 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ropivacaine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROPIVACAINE HYDROCHLORIDE 7.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V910P86109 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905189 Internal RxNorm lookup 1734084 Internal RxNorm lookup 1734207 Internal RxNorm lookup 1734475 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9265-01 Ropivacaine Hydrochloride 20 mL in 1 VIAL, SINGLE-DOSE INJECTION 20 5 0143-9265-10 Ropivacaine Hydrochloride 10 in 1 CARTON INJECTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9265 ROPIVACAINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20230524_35743510-728d-407b-b501-cf019665cd35.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0143-9265-01 00143926501 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 0143-9265-10 00143926510 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9265-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0143-9265-01) 2025-11-18 0000-00-00 No No Current