Home NDC 71288-738 Ropivacaine Hydrochloride
Product NDC 71288-738
11-digit product format 712880738
Labeler code 71288
Product ID 71288-738_f5ce6fdb-2cd1-4ebf-a884-541b2976534f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ropivacaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA218713
Marketing category ANDA
Marketing start 2024-07-30
Substance ROPIVACAINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218713-001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-004 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-005 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-006 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-007 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 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 3 · 91 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 2026-08-18 06:07:40 2026-07 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-006 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-006 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-006 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-006 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-006 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 91 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ropivacaine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROPIVACAINE HYDROCHLORIDE 10 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 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905189 Internal RxNorm lookup 1734084 Internal RxNorm lookup 1734090 Internal RxNorm lookup 1734203 Internal RxNorm lookup 1734207 Internal RxNorm lookup 1734475 Internal RxNorm lookup 1734483 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 71288-738-20 Ropivacaine Hydrochloride 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 3 71288-738-21 Ropivacaine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-738 ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 3 Current NDC, 2 package rows 20240906_d00bfdee-d3e9-4faf-b079-43ac1add51b3.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 Sample Exclude flag Status 71288-738-20 71288073820 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 71288-738-21 71288073821 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-738-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-738-20) 2024-07-30 No No Current