Home NDC 0338-0069 KETOROLAC TROMETHAMINE
Product NDC 0338-0069
11-digit product format 003380069
Labeler code 0338
Product ID 0338-0069_2da4dd8a-1b18-481d-b733-9c031d9ea7e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ketorolac tromethamine
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA209900
Marketing category ANDA
Marketing start 2018-11-30
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 42 .
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 · 84 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 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…2022-03-09 01:35 UTC 2022-03 A209900-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2017-09-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209900-002 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2018-07-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 · 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 0338-0069-10 KETOROLAC TROMETHAMINE 10 in 1 CARTON INJECTION, SOLUTION 10 14 0338-0069-10 KETOROLAC TROMETHAMINE 1 mL in 1 VIAL INJECTION, SOLUTION 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0069 KETOROLAC TROMETHAMINE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 13 Current NDC, Legacy NDC, 2 package rows 20240927_4b58836d-9d58-4539-9691-9e11c505ef2a.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 Marketing end Sample Exclude flag Status 0338-0069-10 00338006910 10 VIAL in 1 CARTON (0338-0069-10) / 1 mL in 1 VIAL 10 vial 2018-11-30 0000-00-00 No No Current