Home NDC 64679-758 KETOROLAC TROMETHAMINE
Product NDC 64679-758
11-digit product format 646790758
Labeler code 64679
Product ID 64679-758_4da5de82-338e-4a91-9b1d-6ee07b04000b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETOROLAC TROMETHAMINE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Wockhardt USA LLC.
Application ANDA077942
Marketing category ANDA
Marketing start 2007-03-27
Marketing end 0000-00-00
Substance KETOROLAC TROMETHAMINE
Active strength 30 mg/mL
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 2 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A077942-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 A077942-002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27
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 · 88 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 2026-10-15 13:18:30 2026-09 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077942-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2007-03-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077942-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2007-03-27 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64679-758-01 2025-12-23 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-02 2025-12-23 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-03 2025-12-23 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-04 2025-12-23 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-05 2025-12-23 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-06 2025-12-23 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-01 2023-01-30 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-02 2023-01-30 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-03 2023-01-30 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-04 2023-01-30 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-05 2023-01-30 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY 64679-758-06 2023-01-30 KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64679-758 KETOROLAC TROMETHAMINE INJECTION [WOCKHARDT USA LLC.] 4 Legacy NDC 20210515_b4b2ee9a-f59d-4c2f-878c-04a870e2a369.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64679-758-01 64679075801 25 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-01) > 1 mL in 1 VIAL, SINGLE-DOSE (64679-758-11) 2007-03-27 0000-00-00 No No Current 64679-758-02 64679075802 25 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-02) > 2 mL in 1 VIAL, SINGLE-DOSE (64679-758-10) 2007-03-27 0000-00-00 No No Current 64679-758-03 64679075803 15 VIAL, MULTI-DOSE in 1 CARTON (64679-758-03) > 10 mL in 1 VIAL, MULTI-DOSE 2007-03-27 0000-00-00 No No Current 64679-758-04 64679075804 10 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-04) > 1 mL in 1 VIAL, SINGLE-DOSE (64679-758-11) 2007-03-27 0000-00-00 No No Current 64679-758-05 64679075805 1 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-05) > 2 mL in 1 VIAL, SINGLE-DOSE (64679-758-10) 2007-03-27 0000-00-00 No No Current 64679-758-06 64679075806 10 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-06) > 2 mL in 1 VIAL, SINGLE-DOSE (64679-758-10) 2007-03-27 0000-00-00 No No Current