NDC 0641-6190-01 - Midazolam
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
- 0641-6190
- Requested NDC
- 0641-6190-01
- Package NDCs from labels
- 0641-6190-01, 0641-6190-10
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Effective date
- 2024-12-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Midazolam Injection, USP - NOVAPLUS® | Hikma Pharmaceuticals USA Inc. | 2024-12-17 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-6190-01 | Midazolam | 10 mL in 1 VIAL | INJECTION | 10 | 8 | |
| 0641-6190-10 | Midazolam | 10 in 1 CARTON | INJECTION | 10 | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6190-01 | ML - Milliliter | 0641-6190 | 584262a2-67e4-4f8c-ae73-73517c84edcc | 1 | 2017-03-06 |
| 0641-6190-10 | ML - Milliliter | 0641-6190 | c556ac86-85c1-47ee-b11a-f8658a537bce | 1 | 2017-03-06 |
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 |
|---|---|---|---|---|---|---|
| HealthWise Lidocaine Plus Cream | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | 16f26249-b508-2c6e-e063-6394a90a265b | 2024-04-25 | Warnings | LKG8494WBH |
| LACTATED RINGERS | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Fresenius Kabi USA, LLC | 7a723a23-3bc1-4f69-b82f-d06a35dc68d6 | 2024-04-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | c1e52670-c85e-4f19-a2e9-bf9abd7c3727 | 2024-04-23 | Warnings, Adverse reactions | 451W47IQ8X |
| PEMF Optimizer | AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 97d57469-4c5b-4d3f-9398-3a1a6617a649 | 2024-04-23 | Warnings | 059QF0KO0R |
| Dermapar | EPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUM | Energique, Inc. | f79fe29b-341e-4bee-9665-1805a7157d1a | 2024-04-22 | Warnings | 451W47IQ8X |
| EVTOX | COCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE | BioActive Nutritional, Inc. | 4b518e10-9ce0-492b-92be-6025d8d7c3c6 | 2024-04-19 | Warnings | QTT17582CB |
| Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | 78ef7ad3-451d-43d0-a9b6-5cf0aadca003 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Hikma Pharmaceuticals USA Inc. | e5ee8caa-b6ca-45ba-98fb-8305e6282141 | 2024-04-10 | Adverse reactions | 451W47IQ8X |
| Midazolam | MIDAZOLAM | Hikma Pharmaceuticals USA Inc. | 8675cdb1-c7f5-40cf-b1e0-0960b7ab117b | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | ANDA075243 311702 W7TTW573JJ |
| Sterile Water | WATER | B. Braun Medical Inc. | 8fc8d87a-3951-4ac5-97df-c161ffc90475 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Hers Plus | CALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALIS | Deseret Biologicals,Inc. | e4636b80-f6c8-459c-8d0e-ff7801358b10 | 2024-04-09 | Warnings | 451W47IQ8X |
| Midazolam | MIDAZOLAM | Hikma Pharmaceuticals USA Inc. | 575d8bf0-7af7-427c-a231-966e2a5e070d | 2024-04-09 | Boxed warning, Warnings, Adverse reactions | ANDA075243 311702 W7TTW573JJ |
| SINU HC | PLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUM | Deseret Biologicals, Inc. | 8b63e066-dd1b-4aee-a17b-4edc6b71a1cc | 2024-04-02 | Warnings | 451W47IQ8X |
| Eye Wash | WATER | M-star (Hubei) Health&Care Products Co., Ltd. | 71706039-e250-4f08-9687-71b2928c4e46 | 2024-04-01 | Warnings | 059QF0KO0R |
| Oral Health | ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS, | Deseret Biologicals, Inc. | 6f66ff40-6e0e-4a35-963c-965c65df76eb | 2024-04-01 | Warnings | QTT17582CB |
| Midazolam | MIDAZOLAM | Hikma Pharmaceuticals USA Inc. | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 2024-03-29 | Boxed warning, Warnings, Adverse reactions | W7TTW573JJ |
| CVS Health Sterile Saline Mist | SODIUM CHLORIDE | CVS Pharmacy | 14931004-1efb-e331-e063-6294a90ad66e | 2024-03-26 | Warnings | 451W47IQ8X |
| Aqua marina | SODIUM CHLORIDE | Boiron | 14945760-30b5-27d3-e063-6394a90a8a32 | 2024-03-26 | 451W47IQ8X | |
| Headache HP | BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM | Energique, Inc. | 5dca8670-c931-47e3-af89-b5f09f5f4e02 | 2024-03-26 | Warnings | 451W47IQ8X |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | B. Braun Medical Inc. | 59ccc717-c374-41c0-be58-9647df881160 | 2024-03-26 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.