FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
47781-584
11-digit product format
477810584
Labeler code
47781
Product ID
47781-584_baae0258-98e2-90c9-f0b7-610b1ee55139
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Alvogen Inc.
Application
ANDA204216
Marketing category
ANDA
Marketing start
2017-09-29
Marketing end
2021-11-01
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-584-68ML - Milliliter47781-584239cc1b7-c566-4bbd-a24c-5a697bf630d312017-11-06
47781-584-93ML - Milliliter47781-5844e30f552-3aee-4f73-8e47-bb2bca80333112017-11-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNfad54f13-52a6-4c4b-9120-46bfffe2808e4
797544isopropyl alcohol 70 % Medicated PadPSNa350fda1-c9bb-4b7a-8fad-a19bd14cd8544
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNfad54f13-52a6-4c4b-9120-46bfffe2808e4
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNa350fda1-c9bb-4b7a-8fad-a19bd14cd8544
1010033lidocaine HCl 1 % Injectable SolutionPSNfad54f13-52a6-4c4b-9120-46bfffe2808e4
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDfad54f13-52a6-4c4b-9120-46bfffe2808e4
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDa350fda1-c9bb-4b7a-8fad-a19bd14cd8544
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfad54f13-52a6-4c4b-9120-46bfffe2808e4
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDa350fda1-c9bb-4b7a-8fad-a19bd14cd8544
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDfad54f13-52a6-4c4b-9120-46bfffe2808e4
797544isopropyl alcohol 70 % Medicated PadSYfad54f13-52a6-4c4b-9120-46bfffe2808e4
797544isopropyl alcohol 70 % Medicated PadSYa350fda1-c9bb-4b7a-8fad-a19bd14cd8544
797544isopropyl alcohol 70 % Topical ClothSYfad54f13-52a6-4c4b-9120-46bfffe2808e4
797544isopropyl alcohol 70 % Topical ClothSYa350fda1-c9bb-4b7a-8fad-a19bd14cd8544
797544isopropyl alcohol 70 % Topical SwabSYa350fda1-c9bb-4b7a-8fad-a19bd14cd8544
797544isopropyl alcohol 70 % Topical SwabSYfad54f13-52a6-4c4b-9120-46bfffe2808e4
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYa350fda1-c9bb-4b7a-8fad-a19bd14cd8544
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYfad54f13-52a6-4c4b-9120-46bfffe2808e4
1010033lidocaine hydrochloride 1 % Injectable SolutionSYfad54f13-52a6-4c4b-9120-46bfffe2808e4
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN137ae784-f651-4f9b-bbb6-fb1f5dd70d7b3
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD137ae784-f651-4f9b-bbb6-fb1f5dd70d7b3
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY137ae784-f651-4f9b-bbb6-fb1f5dd70d7b3
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN69493741-64e8-2d9b-e053-2a91aa0a96ce2
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD69493741-64e8-2d9b-e053-2a91aa0a96ce2
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY69493741-64e8-2d9b-e053-2a91aa0a96ce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-584-684778105846825 VIAL, SINGLE-DOSE in 1 CARTON (47781-584-68) > 1 mL in 1 VIAL, SINGLE-DOSE (47781-584-93) 2017-09-292021-11-01NoNoCurrent