FDA.reportPublic FDA data

KETOROLAC TROMETHAMINE

Product NDC
31722-307
11-digit product format
317220307
Labeler code
31722
Product ID
31722-307_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
60 mg/2mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
KETOROLAC TROMETHAMINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE60 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui860092, 1665459, 1665461

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-307-252024-01-30C16284748780-11030e365-07d8-111a-e063-dadaa90a10e2Ketorolac Tromethamine Injection, USP FOR INTRAVENOUS/INTRAMUSCULAR USE (15 mg and 30 mg) FOR INTRAMUSCULAR USE ONLY (60 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-307-25KETOROLAC TROMETHAMINE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION26
31722-307-25KETOROLAC TROMETHAMINE25 in 1 CARTONINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-307-25ML - Milliliter31722-3071f8d56df-ddf2-4199-ae71-fabce4ebf43b12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-307KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE) INJECTION, SOLUTION [CAMBER PHARMACEUTICALS, INC.]6Current NDC, 2 package rows20241006_478aff0b-29fd-43b2-a701-5236b8f8e3df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN478aff0b-29fd-43b2-a701-5236b8f8e3df6
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN478aff0b-29fd-43b2-a701-5236b8f8e3df6
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN478aff0b-29fd-43b2-a701-5236b8f8e3df6
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD478aff0b-29fd-43b2-a701-5236b8f8e3df6
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD478aff0b-29fd-43b2-a701-5236b8f8e3df6
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD478aff0b-29fd-43b2-a701-5236b8f8e3df6
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY478aff0b-29fd-43b2-a701-5236b8f8e3df6
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY478aff0b-29fd-43b2-a701-5236b8f8e3df6
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY478aff0b-29fd-43b2-a701-5236b8f8e3df6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-307-253172203072525 VIAL, SINGLE-DOSE in 1 CARTON (31722-307-25) / 2 mL in 1 VIAL, SINGLE-DOSE2023-06-20NoNoHistorical