Home NDC 0409-2287 Ketorolac Tromethamine
Product NDC 0409-2287
11-digit product format 004092287
Labeler code 0409
Product ID 0409-2287_85f893d5-95ce-4d57-a40e-bf41a974a09a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETOROLAC TROMETHAMINE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA074993
Marketing category ANDA
Marketing start 2005-04-28
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 · 96 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A074993-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 A074993-002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 1999-01-27
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 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 1999-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 1999-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 1999-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 1999-01-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074993-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 1999-01-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074993-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 1999-01-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded KETOROLAC TROMETHAMINE ACTIVE INGREDIENT 4EVE5946BQ KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 15 KETOROLAC ACTIVE MOIETY YZI5105V0L KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 15 ALCOHOL INACTIVE INGREDIENT 3K9958V90M KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 15 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 15 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 15 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 15 WATER INACTIVE INGREDIENT 059QF0KO0R KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 15 KETOROLAC TROMETHAMINE ACTIVE INGREDIENT 4EVE5946BQ KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 14 KETOROLAC ACTIVE MOIETY YZI5105V0L KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 14 ALCOHOL INACTIVE INGREDIENT 3K9958V90M KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 14 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 14 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 14 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 14 WATER INACTIVE INGREDIENT 059QF0KO0R KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] 14 Ketorolac Tromethamine ACTIVE INGREDIENT 4EVE5946BQ KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 Ketorolac ACTIVE MOIETY YZI5105V0L KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 Alcohol INACTIVE INGREDIENT 3K9958V90M KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] 1
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 0409-2287-31 00409228731 10 CARTRIDGE in 1 CARTON (0409-2287-31) > 1 mL in 1 CARTRIDGE (0409-2287-03) 10 cartridge 2005-04-28 0000-00-00 No No Current 0409-2287-61 00409228761 10 CARTRIDGE in 1 CARTON (0409-2287-61) > 2 mL in 1 CARTRIDGE (0409-2287-04) 10 cartridge 2005-06-23 0000-00-00 No No Current