Home NDC 83270-159 KETOROLAC TROMETHAMINE
Product NDC 83270-159
11-digit product format 832700159
Labeler code 83270
Product ID 83270-159_45964863-b614-400a-e063-6294a90ac151
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETOROLAC TROMETHAMINE
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Onesource Specialty Pharma Limited
Application ANDA201155
Marketing category ANDA
Marketing start 2023-09-30
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 A201155-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 A201155-002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04
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 · 82 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 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 782e0a99824c…
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 860113 Internal RxNorm lookup 860114 Internal RxNorm lookup 860115 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 83270-159-01 KETOROLAC TROMETHAMINE 1 in 1 CARTON INJECTION 1 1 83270-159-01 KETOROLAC TROMETHAMINE 2 mL in 1 SYRINGE, GLASS INJECTION 2 1
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 Sample Exclude flag Status 83270-159-01 83270015901 1 SYRINGE, GLASS in 1 CARTON (83270-159-01) / 2 mL in 1 SYRINGE, GLASS 2023-09-30 No No Current