Ketorolac Tromethamine
- Product NDC
- 47781-585
- 11-digit product format
- 477810585
- Labeler code
- 47781
- Product ID
- 47781-585_baae0258-98e2-90c9-f0b7-610b1ee55139
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- 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 | Effective |
|---|---|---|---|
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| 6a38bd75-79e3-96c0-1204-08a0282902ae | Product name | 4 | 20250128 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 4d6e22a5-3693-6edf-0179-2ab93aecbadb | Product name | 9 | 20240724 |
| 03452e68-2506-686e-a908-f2381c778fc6 | Product name | 5 | 20240307 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| bb41bc3a-c643-93c9-055f-a8f48f363af3 | Product name | 2 | 20190219 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c | Product name | 1 | 20140508 |
| 8d3e992f-8ff7-c106-f7eb-1e2d5eb12025 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 47781-585-46 | ML - Milliliter | 47781-585 | 5f45ef76-f9c4-4f01-ac3b-bfea13f265d3 | 1 | 2018-03-08 |
| 47781-585-68 | ML - Milliliter | 47781-585 | 2bc7412c-c413-4dad-91e1-15ef7e7333da | 1 | 2017-12-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | a350fda1-c9bb-4b7a-8fad-a19bd14cd854 | 4 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | a350fda1-c9bb-4b7a-8fad-a19bd14cd854 | 4 |
| 1010033 | lidocaine HCl 1 % Injectable Solution | PSN | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | a350fda1-c9bb-4b7a-8fad-a19bd14cd854 | 4 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | a350fda1-c9bb-4b7a-8fad-a19bd14cd854 | 4 |
| 1010033 | lidocaine hydrochloride 10 MG/ML Injectable Solution | SCD | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | a350fda1-c9bb-4b7a-8fad-a19bd14cd854 | 4 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | a350fda1-c9bb-4b7a-8fad-a19bd14cd854 | 4 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | a350fda1-c9bb-4b7a-8fad-a19bd14cd854 | 4 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | a350fda1-c9bb-4b7a-8fad-a19bd14cd854 | 4 |
| 1010033 | lidocaine hydrochloride 1 % Injectable Solution | SY | a487b037-982f-467b-b2cf-3f25b2356ab2 | 4 |
| 1665459 | ketorolac tromethamine 60 MG in 2 ML Injection | PSN | 69488fbd-0198-570f-e053-2991aa0af0ed | 2 |
| 1665459 | 2 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 69488fbd-0198-570f-e053-2991aa0af0ed | 2 |
| 1665459 | ketorolac tromethamine 60 MG per 2 ML Injection | SY | 69488fbd-0198-570f-e053-2991aa0af0ed | 2 |
| 1665459 | ketorolac tromethamine 60 MG in 2 ML Injection | PSN | 6dd21587-12ce-4f43-9761-43bc73d96906 | 1 |
| 1665459 | 2 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 6dd21587-12ce-4f43-9761-43bc73d96906 | 1 |
| 1665459 | ketorolac tromethamine 60 MG per 2 ML Injection | SY | 6dd21587-12ce-4f43-9761-43bc73d96906 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 47781-585-68 | 47781058568 | 25 VIAL, SINGLE-DOSE in 1 CARTON (47781-585-68) > 2 mL in 1 VIAL, SINGLE-DOSE (47781-585-46) | 2017-09-29 | 2021-11-01 | No | No | Current |