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Medicine

Ketorolac 30 mg/1 mL injection

Ketorolac · Intramuscular
Available on requestPrescription onlyUS FDAGeneric name

Ketorolac 30 mg/1 mL injection is a generic prescription medicine for intramuscular use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20 to 25°C (68 to 77°F). Protect from light.

Key facts

Active ingredient (INN)
Ketorolac
Brand
Sold under the generic name
Strength
30 mg/1 mL
Dosage form
Injection
Route
Intramuscular
Packs
25 vials of 1 mL, 5 vials of 1 mL, 25 pouches of 1 mL and 6 more
Manufacturers
Sun Pharmaceutical IndustriesIndiaFresenius KabiCardinal HealthHealthFirstMedical Purchasing Solutions
Origin register
US FDA, United States
Storage
Store at 20 to 25°C (68 to 77°F). Protect from light.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
M01AB15 Ketorolac
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
18 October 2000
Identifiers
RxCUI 860092, 1665459, 1665461DailyMed set ID d1920335-8e45-4960-b6e9-e6f1f9e6820c, 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9, f335a030-ffa8-4f42-8166-2f06e036b40d +5NDC 63323-162, 55154-9368, 51662-1594 +3Application ANDA075784, ANDA078737

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose47335-935-45Sun Pharmaceutical IndustriesIndia25 December 2022
25 vial, single-use in 1 tray / 1 mL in 1 vial, single-use63323-162-01Fresenius Kabi18 October 2000
25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose63323-162-12Fresenius Kabi18 October 2000
25 vial, single-use in 1 tray / 1 mL in 1 vial, single-use63323-162-16Fresenius Kabi18 October 2000
25 vial in 1 tray / 1 mL in 1 vial63323-162-51Fresenius Kabi1 October 2024
5 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose55154-9368-5Cardinal Health18 October 2000
5 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose55154-9398-5Cardinal Health18 October 2000
25 pouch in 1 case / 1 vial, single-use in 1 pouch / 1 mL in 1 vial, single-use51662-1594-3HealthFirst22 July 2022
1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose71872-7185-1Medical Purchasing Solutions5 December 2019
25 vial in 1 carton / 1 mL in 1 vial62332-600-25—2 November 2022
25 vial in 1 carton / 1 mL in 1 vial83854-022-25—25 September 2026
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose31722-306-25—20 June 2023
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose65145-145-25—4 October 2024
1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose55150-340-01—20 October 2020
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose55150-340-10—20 October 2020
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose55150-340-25—20 October 2020
10 vial in 1 carton / 1 mL in 1 vial68083-133-10—1 December 2016
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose68462-756-25—19 October 2023
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose47335-934-45—25 December 2022
25 vial in 1 carton / 1 mL in 1 vial0338-0072-25—30 November 2018
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose43066-051-10—19 May 2026
24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass76045-104-10—2 November 2015
24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass76045-209-10—1 September 2020
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose83270-154-03—30 September 2023
1 syringe, glass in 1 carton / 1 mL in 1 syringe, glass83270-158-01—30 September 2023
25 vial in 1 carton / 1 mL in 1 vial72266-118-25—23 June 2023
25 vial in 1 carton / 1 mL in 1 vial0641-6042-25—21 July 2004
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose0409-3795-25—5 January 2026
25 vial in 1 carton / 1 mL in 1 vial25021-701-01—5 September 2014
25 vial in 1 carton / 1 mL in 1 vial70512-843-25—1 July 2023
1 vial in 1 bag / 1 mL in 1 vial71872-7213-1—12 May 2020
1 vial in 1 bag / 1 mL in 1 vial71872-7327-1—21 June 2024
1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose71872-7363-1—7 November 2025
5 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose55154-0120-5—27 July 2011
5 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose55154-7833-5—12 May 2026
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose72572-355-25—25 March 2023
25 vial in 1 carton / 1 mL in 1 vial72572-357-25—1 April 2026
25 vial in 1 carton / 1 mL in 1 vial85766-064-25—17 September 2025
25 vial in 1 carton / 1 mL in 1 vial85766-298-25—22 October 2026
25 vial in 1 carton / 1 mL in 1 vial50090-5428-0—23 June 2023
1 mL in 1 vial50090-5428-1—23 June 2023
1 vial in 1 bag / 1 mL in 1 vial0404-9996-01—25 August 2023
1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose71205-582-01—12 July 2021
1 mL in 1 vial84549-701-01—18 September 2025
25 vial in 1 carton / 1 mL in 1 vial70518-2927-0—30 October 2020

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 30 November 1989Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Ketorolac 30 mg/1 mL injection.

Compare 1

Other strengths and forms of Ketorolac

Clinical summary

Ketorolac is a cyclooxygenase inhibitor indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis, among other approved uses. It is available as injection, tablets and eye drops for intramuscular, intravenous and oral use. MedsAcross supplies Ketorolac for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Ketorolac

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

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