Home NDC 55150-341 KETOROLAC TROMETHAMINE
Product NDC 55150-341
11-digit product format 551500341
Labeler code 55150
Product ID 55150-341_74f71a7a-b89a-4ad2-a19d-4f2fb87b040f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETOROLAC TROMETHAMINE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Eugia US LLC
Application ANDA212939
Marketing category ANDA
Marketing start 2020-10-20
Substance KETOROLAC TROMETHAMINE
Active strength 60 mg/2mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 A212939-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 A212939-002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20
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 · 72 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 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2020-10-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2020-10-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212939-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2020-10-20 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212939-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-10-20 87673890dc5c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base KETOROLAC TROMETHAMINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOROLAC TROMETHAMINE 60 mg/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4EVE5946BQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860092 Internal RxNorm lookup 1665459 Internal RxNorm lookup 1665461 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 55150-341-01 KETOROLAC TROMETHAMINE 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 4 55150-341-01 KETOROLAC TROMETHAMINE 1 in 1 CARTON INJECTION, SOLUTION 1 4 55150-341-25 KETOROLAC TROMETHAMINE 25 in 1 CARTON INJECTION, SOLUTION 25 4 55150-341-25 KETOROLAC TROMETHAMINE 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-341 KETOROLAC TROMETHAMINE INJECTION, SOLUTION [EUGIA US LLC] 4 Current NDC, Legacy NDC, 4 package rows 20240802_f520978f-9046-4ff8-b04d-0f615fdeae4d.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55150-341-01 55150034101 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-341-01) / 2 mL in 1 VIAL, SINGLE-DOSE 2020-10-20 0000-00-00 No No Current 55150-341-25 55150034125 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-341-25) / 2 mL in 1 VIAL, SINGLE-DOSE 2020-10-20 0000-00-00 No No Current