Home NDC 31722-686 Ketorolac Tromethamine
Product NDC 31722-686
11-digit product format 317220686
Labeler code 31722
Product ID 31722-686_eb4bc57d-9d4e-14b8-e053-2a95a90a8729
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA216651
Marketing category ANDA
Marketing start 2022-08-25
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 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 A216651-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216651-001 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 2026-02-19 14:30 UTC 2026-02 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216651-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2022-08-25 a50c72e98297…
Observed Orange Book normalized TE history# 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 31722-686-01 Ketorolac Tromethamine 100 in 1 BOTTLE TABLET, FILM COATED 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-686 KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20221019_e1fb8753-4695-4cb2-83d7-15d79fbaeeb2.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ketorolac Tromethamine KETOROLAC TROMETHAMINE Injecta Medcial LLC 515464a7-16c5-2811-e063-6294a90aa451 2026-06-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216651 application number: ANDA216651 Ketorolac Tromethamine KETOROLAC TROMETHAMINE Injecta Medcial LLC 521b3d09-df08-fcae-e063-6294a90a6545 2026-05-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216651 application number: ANDA216651 Ketorolac Tromethamine KETOROLAC TROMETHAMINE A-S Medication Solutions 49e04373-568d-48fa-ac1c-b7d6b493e777 2025-10-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216651 application number: ANDA216651 Ketorolac Tromethamine KETOROLAC TROMETHAMINE Advanced Rx of Tennessee, LLC 2cf7516b-ac86-ca72-e063-6394a90a4339 2025-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216651 application number: ANDA216651 Ketorolac Tromethamine KETOROLAC TROMETHAMINE Camber Pharmaceuticals, Inc. e1fb8753-4695-4cb2-83d7-15d79fbaeeb2 2022-10-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216651 application number: ANDA216651 ndc (product): 31722-686
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 31722-686-01 31722068601 100 TABLET, FILM COATED in 1 BOTTLE (31722-686-01) 2022-08-25 0000-00-00 No No Current