Home NDC 72572-354 Ketorolac Tromethamine
Product NDC 72572-354
11-digit product format 725720354
Labeler code 72572
Product ID 72572-354_36757566-9551-4adc-8783-3f5054c370e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETOROLAC TROMETHAMINE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Civica, Inc.
Application ANDA209900
Marketing category ANDA
Marketing start 2023-03-25
Substance KETOROLAC TROMETHAMINE
Active strength 15 mg/mL
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 43 .
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 A209900-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 A209900-002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25
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 · 86 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 2026-09-14 22:38:34 2026-08 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 15 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860092 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 72572-354-01 Ketorolac Tromethamine 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 3 72572-354-10 Ketorolac Tromethamine 10 in 1 CARTON INJECTION, SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72572-354 KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CIVICA, INC.] 3 Current NDC, 2 package rows 20241108_1e8ddf13-c513-4e16-a91a-9d55726d9071.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72572-354-01 72572035401 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 72572-354-10 72572035410 10 VIAL, SINGLE-DOSE in 1 CARTON (72572-354-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72572-354-01) 2023-03-25 No No Current