Home NDC 17478-082 Ropivacaine Hydrochloride
Product NDC 17478-082
11-digit product format 174780082
Labeler code 17478
Product ID 17478-082_32112fae-3aee-4166-affc-595e6c6890cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ropivacaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; PERINEURAL
Labeler Akorn
Application ANDA204636
Marketing category ANDA
Marketing start 2018-03-16
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A204636-001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 A204636-002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16
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 3 · 88 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 2026-10-15 13:18:30 2026-09 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204636-001 ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204636-002 ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION / INJECTION AP 2018-03-16 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17478-082-90 Ropivacaine Hydrochloride 6 in 1 CARTON INJECTION, SOLUTION 6 7 17478-082-90 Ropivacaine Hydrochloride 100 mL in 1 BOTTLE INJECTION, SOLUTION 100 7 17478-082-92 Ropivacaine Hydrochloride 6 in 1 CARTON INJECTION, SOLUTION 6 7 17478-082-92 Ropivacaine Hydrochloride 200 mL in 1 BOTTLE INJECTION, SOLUTION 200 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-082 ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AKORN] 7 Legacy NDC, 4 package rows 20220916_3f538ea5-1e08-4fb5-9756-696ac3d817a3.zip
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 17478-082-90 17478008290 6 BOTTLE in 1 CARTON (17478-082-90) > 100 mL in 1 BOTTLE 6 bottle 2018-03-16 0000-00-00 No No Current 17478-082-92 17478008292 6 BOTTLE in 1 CARTON (17478-082-92) > 200 mL in 1 BOTTLE 6 bottle 2018-03-16 0000-00-00 No No Current