Home NDC 0338-0076-10 KETOROLAC TROMETHAMINE
Product NDC 0338-0076
Requested package NDC 0338-0076-10
11-digit product format 003380076
Labeler code 0338
Product ID 0338-0076_2597b2d3-f232-4401-9cdd-403ef6b79ee4
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
Marketing end 0000-00-00
Substance KETOROLAC TROMETHAMINE
Active strength 15 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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0338-0076 0338-0076-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0338-0076 0338-0076-10 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-0076-10 KETOROLAC TROMETHAMINE 10 in 1 CARTON INJECTION, SOLUTION 10 14 0338-0076-10 KETOROLAC TROMETHAMINE 2 mL in 1 VIAL INJECTION, SOLUTION 2 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0076 KETOROLAC TROMETHAMINE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 13 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 0338-0076-10 00338007610 10 VIAL in 1 CARTON (0338-0076-10) > 2 mL in 1 VIAL 10 vial 2018-11-30 0000-00-00 No No Current