Home NDC 47335-935 ketorolac tromethamine
Product NDC 47335-935
11-digit product format 473350935
Labeler code 47335
Product ID 47335-935_4d86168f-6d0f-4338-8e59-9ad241a9fadb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ketorolac tromethamine
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA078737
Marketing category ANDA
Marketing start 2022-12-25
Substance KETOROLAC TROMETHAMINE
Active strength 60 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 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078737-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2008-10-06 A078737-002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2008-10-06
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2008-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2008-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2008-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2008-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2008-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2008-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2008-10-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2008-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2008-10-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2008-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2008-10-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2008-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2008-10-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2008-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2008-10-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2008-10-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2008-10-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2008-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078737-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2008-10-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078737-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2008-10-06 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 60 mg/2mL
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 47335-935-40 ketorolac tromethamine 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 9 47335-935-45 ketorolac tromethamine 25 in 1 CARTON INJECTION 25 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-935 KETOROLAC TROMETHAMINE INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20240805_29a92a7c-68d1-489b-ba27-d788b3153795.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 47335-935-40 47335093540 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 47335-935-45 47335093545 25 VIAL, SINGLE-DOSE in 1 CARTON (47335-935-45) / 1 mL in 1 VIAL, SINGLE-DOSE (47335-935-40) 2022-12-25 0000-00-00 No No Current