Home NDC 0409-9300 Ropivacaine Hydrochloride
Product NDC 0409-9300
11-digit product format 004099300
Labeler code 0409
Product ID 0409-9300_0669f092-f34e-40c2-af54-8004c205032d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ROPIVACAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; PERINEURAL
Labeler Hospira, Inc.
Application ANDA090194
Marketing category ANDA
Marketing start 2014-11-07
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090194-001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 A090194-002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION 2014-09-23 A090194-003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION 2014-09-23 A090194-004 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 A090194-005 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 A090194-006 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION 2014-09-23
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 7 · 252 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 A090194-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090194-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION 2014-09-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090194-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION 2014-09-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090194-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090194-005 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090194-006 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090194-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090194-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION 2014-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090194-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION 2014-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090194-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090194-005 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090194-006 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090194-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090194-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION 2014-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090194-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION 2014-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090194-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090194-005 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090194-006 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090194-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090194-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION 2014-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090194-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION 2014-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090194-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090194-005 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090194-006 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090194-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090194-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION 2014-09-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090194-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION 2014-09-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090194-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090194-005 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090194-006 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090194-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090194-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION 2014-09-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090194-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION 2014-09-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090194-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090194-005 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090194-006 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090194-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION 2014-09-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090194-002 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION 2014-09-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090194-003 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION 2014-09-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090194-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION 2014-09-23 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 162 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ROPIVACAINE HYDROCHLORIDE ACTIVE INGREDIENT V910P86109 ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 ROPIVACAINE ACTIVE MOIETY 7IO5LYA57N ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0409-9300-10 00409930010 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9300-10) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-9300-11) 2014-11-07 0000-00-00 No No Current 0409-9300-20 00409930020 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9300-20) > 20 mL in 1 VIAL, SINGLE-DOSE (0409-9300-21) 2014-11-07 0000-00-00 No No Current