Home NDC 31722-305-25 KETOROLAC TROMETHAMINE
Product NDC 31722-305
Requested package NDC 31722-305-25
11-digit product format 317220305
Labeler code 31722
Product ID 31722-305_23a5daec-e083-eec0-e063-6394a90a2411
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETOROLAC TROMETHAMINE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Camber Pharmaceuticals, Inc.
Application ANDA217166
Marketing category ANDA
Marketing start 2023-06-20
Substance KETOROLAC TROMETHAMINE
Active strength 15 mg/mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217166-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 A217166-002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20
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 2 · 42 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 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217166-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2023-06-20 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217166-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2023-06-20 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 15 mg/mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860092 Internal RxNorm lookup 1665459 Internal RxNorm lookup 1665461 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 31722-305-10 KETOROLAC TROMETHAMINE 10 in 1 CARTON INJECTION, SOLUTION 10 6 31722-305-10 KETOROLAC TROMETHAMINE 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 6 31722-305-25 KETOROLAC TROMETHAMINE 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 6 31722-305-25 KETOROLAC TROMETHAMINE 25 in 1 CARTON INJECTION, SOLUTION 25 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-305 KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE) INJECTION, SOLUTION [CAMBER PHARMACEUTICALS, INC.] 6 Current NDC, 4 package rows 20241006_478aff0b-29fd-43b2-a701-5236b8f8e3df.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 · 1 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 31722-305-25 31722030525 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-305-25) / 1 mL in 1 VIAL, SINGLE-DOSE 2023-06-20 No No Current