Home NDC 55289-328 Ketorolac Tromethamine
Product NDC 55289-328
11-digit product format 552890328
Labeler code 55289
Product ID 55289-328_d9a63bfa-1135-abd2-e053-2a95a90a8176
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA074761
Marketing category ANDA
Marketing start 2013-05-16
Marketing end 0000-00-00
Substance KETOROLAC TROMETHAMINE
Active strength 10 mg/1
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 2 · 72 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074761-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074761-001 AB
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 2 · 41 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 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB RS 1997-05-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB RS 1997-05-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB RS 1997-05-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB RS 1997-05-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074761-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 1997-05-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded KETOROLAC TROMETHAMINE ACTIVE INGREDIENT 4EVE5946BQ KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 KETOROLAC ACTIVE MOIETY YZI5105V0L KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-328-10 55289032810 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-328-10) 2013-05-31 0000-00-00 No No Current 55289-328-12 55289032812 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-328-12) 2013-05-31 0000-00-00 No No Current 55289-328-15 55289032815 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-328-15) 2013-05-31 0000-00-00 No No Current 55289-328-20 55289032820 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-328-20) 2013-05-31 0000-00-00 No No Current 55289-328-30 55289032830 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-328-30) 2013-05-31 0000-00-00 No No Current