NDC 0641-6041-01 - Ketorolac Tromethamine
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0641-6041
- Requested NDC
- 0641-6041-01
- Package NDCs from labels
- 0641-6041-01, 0641-6041-25
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Effective date
- 2024-04-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Ketorolac Tromethamine - Hikma Pharmaceuticals USA Inc. | Hikma Pharmaceuticals USA Inc. | 2024-04-10 | HUMAN PRESCRIPTION DRUG LABEL |
| Ketorolac Tromethamine Injection, USP | General Injectables and Vaccines, Inc. | 2018-07-02 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2013-02-13 | Indexing - Billing Unit |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-6041-01 | Ketorolac Tromethamine | 1 mL in 1 VIAL | INJECTION | 1 | 13 | |
| 0641-6041-25 | Ketorolac Tromethamine | 25 in 1 CARTON | INJECTION | 25 | 13 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6041-01 | ML - Milliliter | 0641-6041 | de1e773b-19d1-4632-93ac-345ac50a1449 | 1 | 2013-02-13 |
| 0641-6041-25 | ML - Milliliter | 0641-6041 | ad136187-25b4-4f4d-ab41-60a269c4d8cb | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | ACTIVE INGREDIENT | 4EVE5946BQ | KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| KETOROLAC | ACTIVE MOIETY | YZI5105V0L | KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| COTTON ON FOUNDATION Tropical Hand Sanitizer | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 3645359c-06a2-4b97-b982-c54e4a0b8cda | 2024-09-04 | Warnings | 3K9958V90M |
| COTTON ON FOUNDATION Coastal Hand Sanitizer | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 645c09dc-15a4-481f-a605-f12fb8f8e9bd | 2024-09-04 | Warnings | 3K9958V90M |
| Adrenal Liquescence | GLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA (AMERICAN GINSENG), GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, EPHEDRA VULGARIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHIN | Nutritional Specialties, Inc. | 9f8e7917-33df-4059-9ae9-e3d2fbb8e319 | 2024-09-03 | Warnings | 451W47IQ8X |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Mylan Pharmaceuticals Inc. | 2837a082-3a34-6f81-5e43-45a70295686b | 2024-08-31 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Gum Therapy | ACONITUM NAPELLUS, ARNICA MONTANA, BISMUTHUM SUBNITRICUM, BORAX, CALCAREA FLUORICA, CALENDULA OFFICINALIS, CISTUS CANADENSIS, HEPAR SULPHURIS CALCAREUM, KALI PHOSPHORICUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NATRUM MURIATICUM, SEPIA | Deseret Biologicals | ceb5203b-b4c8-4c7b-8e18-ccbff5034fc1 | 2024-08-29 | Warnings | 451W47IQ8X |
| BERRIS AND CREAMY SCENTED HAND SANITIZER | ALCOHOL | Ganzhou Olivee Cosmetic Co., Ltd. | 30fc7f33-238c-42a3-93a1-72b98d303d9a | 2024-08-28 | Warnings | 3K9958V90M |
| MANGO SORBET SCENTED HAND SANITIZER | ALCOHOL | Ganzhou Olivee Cosmetic Co., Ltd. | d44e43e1-717d-47a1-a152-45f12288cbd2 | 2024-08-28 | Warnings | 3K9958V90M |
| COCONUT VANILLA SCENTED HAND SANITIZER | ALCOHOL | Ganzhou Olivee Cosmetic Co., Ltd. | 574324ee-d98b-4939-889c-21ed04a4e46d | 2024-08-28 | Warnings | 3K9958V90M |
| STRAWBERRY SHORTCAKE SCENTED HAND SANITIZER | ALCOHOL | Ganzhou Olivee Cosmetic Co., Ltd. | 997d0ff0-96b4-4b91-87fc-8f67d9b5013c | 2024-08-28 | Warnings | 3K9958V90M |
| Gum Therapy | CALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, BORAX, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUS | Deseret Biologicals | 5c741edc-f3ce-4e43-bb3e-fb7316621406 | 2024-08-28 | Warnings | 451W47IQ8X |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Aurobindo Pharma Limited | e93f6501-827d-474c-b660-765b7c0fb871 | 2024-08-26 | Warnings, Adverse reactions | 4EVE5946BQ |
| Upper Respiratory Support | ALLIUM CEPA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, SALVIA OFFICINALIS, DULCAMARA, EUPHRASIA OFFICINALIS, HYDRASTIS CANADENSIS, NATRUM MURIATICUM, SABADILLA, VISCUM ALBUM, MUCOSA NASALIS SUIS, ACONITUM NAPELLUS, AMMONIUM CARBONICUM, ARSENICUM IODATUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (PRATENSIS), RHUS TOX | Deseret Biologicals, Inc. | 882a284f-aa25-40cf-8aff-fe4c38ff3f0a | 2024-08-23 | Warnings | 451W47IQ8X |
| hand sanitizer 01 | ALCOHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 202dfeac-6e69-8667-e063-6294a90a26d2 | 2024-08-21 | Warnings | 3K9958V90M |
| antibacterial hand sanitizer gel 01 | ALCOHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 202e5c15-8749-0a76-e063-6294a90a2720 | 2024-08-21 | Warnings | 3K9958V90M |
| PDI Sani-Hands Instant Hand Sanitizing Wipes | ALCOHOL | Professional Disposables International, Inc. | d43b7f97-4ecb-4b81-a975-c02f516dcaef | 2024-08-20 | Warnings | 3K9958V90M |
| Sani Professional Hands Instant Sanitizing Wipes | ALCOHOL | Professional Disposables International, Inc. | 96d92653-2b7d-6fd0-e053-2995a90ae04d | 2024-08-20 | Warnings | 3K9958V90M |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals, Inc. | 415a5393-296f-30e3-e054-00144ff8d46c | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals, Inc. | 46dc8f62-e754-50e3-e054-00144ff8d46c | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Quality Choice Effervescent Antacid and Pain Relief - Extra Strength | ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE | Chain Drug Marketing Association | 1f926637-a61c-8eb7-e063-6394a90a6502 | 2024-08-13 | Warnings | XF417D3PSL |
| Empathy | AETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATA | Deseret Biologicals, Inc. | a89067c1-ef12-49da-8fa6-e65ff664f497 | 2024-08-13 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.