Home NDC 70069-061 Ropivacaine Hydrochloride
Product NDC 70069-061
11-digit product format 700690061
Labeler code 70069
Product ID 70069-061_79b226f0-c08a-4f84-bf2b-ae5c60e01d67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ropivacaine Hydrochloride
Dosage form INJECTION
Route EPIDURAL; INFILTRATION; PERINEURAL
Labeler Somerset Therapeutics, LLC
Application ANDA207636
Marketing category ANDA
Marketing start 2018-06-15
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 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 A207636-001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 A207636-002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 A207636-003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 A207636-004 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 A207636-005 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2018-06-15 A207636-006 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 A207636-007 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15
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 8 · 294 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 A207636-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207636-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207636-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207636-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207636-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2018-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207636-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207636-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207636-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207636-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207636-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207636-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207636-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2018-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207636-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207636-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207636-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207636-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207636-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207636-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207636-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2018-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207636-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207636-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207636-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207636-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207636-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207636-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207636-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2018-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207636-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207636-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207636-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207636-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207636-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207636-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207636-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2018-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207636-006 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207636-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2018-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207636-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207636-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2018-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207636-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207636-004 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2018-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207636-005 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2018-06-15 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 294 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 · 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 70069-061-01 Ropivacaine Hydrochloride 10 mL in 1 VIAL INJECTION 10 13 70069-061-10 Ropivacaine Hydrochloride 10 in 1 CARTON INJECTION 10 13 70069-061-25 Ropivacaine Hydrochloride 25 in 1 CARTON INJECTION 25 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-061 ROPIVACAINE HYDROCHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC] 12 Current NDC, Legacy NDC, 3 package rows 20221110_ffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe64.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 · 3 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 70069-061-01 70069006101 10 mL in 1 VIAL 10 ml Historical 70069-061-10 70069006110 10 VIAL in 1 CARTON (70069-061-10) / 10 mL in 1 VIAL (70069-061-01) 10 vial 2022-03-02 0000-00-00 No No Current 70069-061-25 70069006125 25 VIAL in 1 CARTON (70069-061-25) / 10 mL in 1 VIAL (70069-061-01) 25 vial 2018-06-15 0000-00-00 No No Current