Home NDC 25021-671-87 ropivacaine hydrochloride
Product NDC 25021-671
Requested package NDC 25021-671-87
11-digit product format 250210671
Labeler code 25021
Product ID 25021-671_22d83514-0f7b-4671-ae6a-7ca47449c184
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ropivacaine hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION
Labeler Sagent Pharmaceuticals
Application ANDA206166
Marketing category ANDA
Marketing start 2020-01-01
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 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 A206166-001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 A206166-002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 A206166-003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 A206166-004 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11
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 5 · 172 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 A206166-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206166-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206166-003 ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206166-004 ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206166-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206166-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206166-003 ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206166-004 ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206166-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206166-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206166-003 ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206166-004 ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206166-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206166-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206166-003 ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206166-004 ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206166-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206166-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206166-003 ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206166-004 ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206166-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206166-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206166-003 ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206166-004 ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206166-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206166-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206166-003 ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206166-004 ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206166-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206166-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206166-003 ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206166-004 ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206166-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206166-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206166-003 ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206166-004 ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206166-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206166-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206166-003 ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206166-004 ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-11 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 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 25021-671-82 ropivacaine hydrochloride 100 mL in 1 BAG INJECTION, SOLUTION 100 11 25021-671-82 ropivacaine hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 11 25021-671-87 ropivacaine hydrochloride 200 mL in 1 BAG INJECTION, SOLUTION 200 11 25021-671-87 ropivacaine hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 11 25021-671-66 ropivacaine hydrochloride 100 mL in 1 BAG INJECTION, SOLUTION 100 5 25021-671-66 ropivacaine hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 5 25021-671-67 ropivacaine hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 5 25021-671-67 ropivacaine hydrochloride 200 mL in 1 BAG INJECTION, SOLUTION 200 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-671 ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 10 Current NDC, Legacy NDC, 4 package rows 20240328_8c5c762f-d266-4b1a-809e-f11bfc89bc2d.zip 25021-671 ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 4 package rows 20240328_9572b3de-684c-4028-a577-5aa69ba6b02d.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 25021-671-87 25021067187 10 BAG in 1 CARTON (25021-671-87) / 200 mL in 1 BAG 10 bag 2018-12-15 0000-00-00 No No Current