Home NDC 72789-437-10 KETOROLAC TROMETHAMINE
Product NDC 72789-437
Requested package NDC 72789-437-10
11-digit product format 727890437
Labeler code 72789
Product ID 72789-437_3a25208f-aeec-f466-e063-6294a90a92ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETOROLAC TROMETHAMINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA215745
Marketing category ANDA
Marketing start 2024-03-01
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A215745-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215745-001 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.
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 2026-09-14 22:38:34 2026-08 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215745-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2023-02-23 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 10 mg/1
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 834022 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 72789-437-01 KETOROLAC TROMETHAMINE 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 12 72789-437-10 KETOROLAC TROMETHAMINE 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 12 72789-437-20 KETOROLAC TROMETHAMINE 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-437 KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 Current NDC, 3 package rows 20241114_862dd7b7-8ed5-42bf-870e-a45b86740226.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72789-437-10 72789043710 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-10) 2024-11-11 No No Current