NDC 71288-040-64 - Xenleta
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
- 71288-040
- Requested NDC
- 71288-040-64
- Package NDCs from labels
- 71288-040-64, 71288-040-65
- Manufacturer
- Meitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd. | Almac Pharma Services Limited | Gland Pharma Limited
- Effective date
- 2026-07-22
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Xenleta | Meitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd. | Almac Pharma Services Limited | Gland Pharma Limited | 2026-07-22 | HUMAN PRESCRIPTION DRUG LABEL |
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 |
|---|---|---|---|---|---|---|
| Garzulys | INSULIN ASPART-FSAN | Meitheal Pharmaceuticals Inc. | 30c64769-d2f7-4604-ac9e-2a6bc09506c9 | 2026-07-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Muscle Ice | PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS) | Peaceful Mountain, Inc. | 03b6e2a9-f335-4ae2-9011-80bd019afb72 | 2026-07-30 | Warnings | ETJ7Z6XBU4 |
| Bioplasma | SILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDE | Hyland's Inc. | dd0a7ed2-d112-4b96-e053-2995a90ac6b6 | 2026-07-30 | Warnings | ETJ7Z6XBU4 451W47IQ8X |
| Hypertonic Saline | SODIUM CHLORIDE | NAVEH PHARMA (1996) LTD | 167c7a9c-1228-4fb2-a89c-d3e148386323 | 2026-07-30 | Warnings | 451W47IQ8X |
| Hypertonic Saline Solution Sodium Chloride | SODIUM CHLORIDE | NAVEH PHARMA (1996) LTD | 750ea4b1-de2b-4299-aaa2-331daf383d0d | 2026-07-30 | Warnings | 451W47IQ8X |
| DECONIMO Reconstitution | DECONIMO RECONSTITUTION | Image Amazon LLC | 57ab9b1c-9a18-3786-e063-6394a90a2c63 | 2026-07-28 | Warnings | 059QF0KO0R |
| Delflex | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care de Mexico, S.A. de C.V. | a98facd6-9daa-4d37-8209-63a0599dbfaa | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Medical Care de Mexico, S.A. de C.V. | 9a1220fb-6853-45ae-838c-10d8596e1af7 | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | af5cdf1a-19f4-11e2-892e-0800200c9a66 | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| PEG 3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | A-S Medication Solutions | 19daf830-7270-4661-81b1-ded38f867f28 | 2026-07-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Xenleta | LEFAMULIN ACETATE | Meitheal Pharmaceuticals Inc. | eb972ea8-7502-422e-84bb-66cb8e93ca06 | 2026-07-22 | Warnings, Adverse reactions | NDA211673 NDA211672 71288-040-64 71288-039-16 71288-037-10 71288-039-15 71288-040-65 71288-037 71288-040 71288-039 71288004064 2747671 2198966 2747672 2198961 2198948 2198953 b9951406-492b-4420-89cc-24fd655824b3 eb972ea8-7502-422e-84bb-66cb8e93ca06 HDN0B924X4 XF417D3PSL |
| Sterile Water | WATER | Cardinal Health 107, LLC | 9655cd02-82b5-4a75-813b-854b19551481 | 2026-07-21 | Warnings, Adverse reactions | 059QF0KO0R |
| Whisidom Saline Solution | SODIUM CHLORIDE 0.9% SALINE SOLUTION | Jiangxi Yudexi Pharmaceutical Co., LTD | 4e4e4169-2a14-3466-e063-6394a90a081b | 2026-07-20 | Warnings | 451W47IQ8X |
| Saline | NASAL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 71485e82-bf54-4b8b-8dd2-2a0761534520 | 2026-07-17 | Warnings | 451W47IQ8X |
| Prid | ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR | Hyland's Inc. | 49689eeb-7790-07f1-e063-6294a90a2df2 | 2026-07-16 | Warnings | ETJ7Z6XBU4 |
| Leg Cramps PM | OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR | Hyland's Inc. | b0574a7e-88fa-417e-b6d5-60ced59eba47 | 2026-07-15 | Warnings | ETJ7Z6XBU4 |
| Sodium Chloride | SODIUM CHLORIDE | LABORATORIOS GRIFOLS SA | eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf | 2026-07-15 | Warnings, Adverse reactions | 451W47IQ8X |
| WHWSWB 0.9% SALINE | SODIUM CHLORIDE | Yiwu Huanshu E-commerce Co., Ltd | 5082b773-79b2-2501-e063-6394a90a170f | 2026-07-11 | Warnings | 451W47IQ8X |
| Jacksons Cell Salts SILICA 12X 12 | SILICEA | Zettl Health Inc. | 5647dafc-1fff-6a25-e063-6294a90a8b4f | 2026-07-10 | ETJ7Z6XBU4 | |
| SALINE NASAL | SODIUM CHLORIDE | ALAINA HEALTHCARE PRIVATE LIMITED | ed30a7f9-7132-42da-9bed-63a9b1c80ab2 | 2026-07-07 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.