Home NDC 68083-262-01 Ropivacaine hydrochloride
Product NDC 68083-262
Requested package NDC 68083-262-01
11-digit product format 680830262
Labeler code 68083
Product ID 68083-262_59ffca85-dbbf-49c1-8516-027b9de5f396
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ropivacaine hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION
Labeler Gland Pharma Limited
Application ANDA210102
Marketing category ANDA
Marketing start 2022-08-18
Substance ROPIVACAINE HYDROCHLORIDE
Active strength 2 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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210102-001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 A210102-002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 54 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 2026-02-19 14:30 UTC 2026-02 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210102-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210102-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2022-08-18 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 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 2 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1734347 Internal RxNorm lookup 1734355 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 68083-262-01 Ropivacaine hydrochloride 100 mL in 1 BAG INJECTION, SOLUTION 100 6 68083-262-01 Ropivacaine hydrochloride 1 in 1 POUCH INJECTION, SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-262 ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20220824_643c1729-096e-459c-80c1-78b78e698da6.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.
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 68083-262-01 68083026201 1 BAG in 1 POUCH (68083-262-01) / 100 mL in 1 BAG 1 bag 2022-08-18 0000-00-00 No No Current