Home NDC 0487-6232 Ketorolac Tromethamine
Product NDC 0487-6232
11-digit product format 004876232
Labeler code 0487
Product ID 0487-6232_47e5aabd-6afa-7c55-e063-6394a90a2e81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Nephron Pharmaceuticals Corporation
Application ANDA211445
Marketing category ANDA
Marketing start 2020-09-08
Substance KETOROLAC TROMETHAMINE
Active strength 30 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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211445-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211445-001 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.
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 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211445-001 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2020-08-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 30 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665459 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 0487-6232-01 Ketorolac Tromethamine 2 mL in 1 VIAL INJECTION 2 4 0487-6232-01 Ketorolac Tromethamine 30 in 1 CARTON INJECTION 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0487-6232 KETOROLAC TROMETHAMINE INJECTION [NEPHRON SC INC.] 3 Current NDC, Legacy NDC, 2 package rows 20241220_ae6c60c0-e88a-45b2-e053-2995a90ac62f.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 0487-6232-01 00487623201 30 VIAL in 1 CARTON (0487-6232-01) / 2 mL in 1 VIAL 30 vial 2020-09-08 0000-00-00 No No Current