Home NDC 76045-107-10 Ketorolac Tromethamine
Product NDC 76045-107
Requested package NDC 76045-107-10
11-digit product format 760450107
Labeler code 76045
Product ID 76045-107_0dab642d-7fcf-4301-8ac9-10e64a040c6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA203242
Marketing category ANDA
Marketing start 2015-11-02
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 2027-12-31
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 A203242-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2015-10-07 A203242-002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203242-002 AP
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 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2015-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2015-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2015-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2015-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2015-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203242-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2015-10-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203242-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2015-10-07 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 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 2027-12-31 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 · 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 76045-107-10 Ketorolac Tromethamine 24 in 1 CARTON INJECTION, SOLUTION 24 17 76045-107-10 Ketorolac Tromethamine 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ketorolac Tromethamine ACTIVE INGREDIENT 4EVE5946BQ KETOROLAC TROMETHAMINE INJECTION, SOLUTION [BD RX, INC.] 6 Ketorolac ACTIVE MOIETY YZI5105V0L KETOROLAC TROMETHAMINE INJECTION, SOLUTION [BD RX, INC.] 6 Alcohol INACTIVE INGREDIENT 3K9958V90M KETOROLAC TROMETHAMINE INJECTION, SOLUTION [BD RX, INC.] 6 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB KETOROLAC TROMETHAMINE INJECTION, SOLUTION [BD RX, INC.] 6 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X KETOROLAC TROMETHAMINE INJECTION, SOLUTION [BD RX, INC.] 6 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I KETOROLAC TROMETHAMINE INJECTION, SOLUTION [BD RX, INC.] 6 Water INACTIVE INGREDIENT 059QF0KO0R KETOROLAC TROMETHAMINE INJECTION, SOLUTION [BD RX, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76045-107 KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 17 Current NDC, Legacy NDC, 2 package rows 20230910_3d88cbe6-5230-47aa-80af-0c41283d1f00.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 Units Marketing start Marketing end Sample Exclude flag Status 76045-107-10 76045010710 24 BLISTER PACK in 1 CARTON (76045-107-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS 24 blister pack 2015-11-02 0000-00-00 No No Current