NDC 58468-0080-01 - Thymoglobulin
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
- 58468-0080
- Requested NDC
- 58468-0080-01
- Package NDCs from labels
- 58468-0080-1, 58468-0080-01
- Manufacturer
- Genzyme Corporation | SANOFI WINTHROP INDUSTRIE | Genzyme Ireland Limited
- Effective date
- 2026-06-24
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Thymoglobulin - Genzyme Corporation | SANOFI WINTHROP INDUSTRIE | Genzyme Ireland Limited | Genzyme Corporation | SANOFI WINTHROP INDUSTRIE | Genzyme Ireland Limited | 2026-06-24 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58468-0080-1 | Thymoglobulin | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 | 21 | |
| 58468-0080-1 | Thymoglobulin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 21 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58468-0080 | THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] | 18 | Current NDC, Legacy NDC, 2 package rows | 20241012_bbd8ab99-552e-4b81-aca4-6b0c7af8b9ae.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58468-0080-1 | EA - Each | 58468-0080 | 75d13bad-4e91-4271-b268-d55c0cefde79 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | ACTIVE INGREDIENT | D7RD81HE4W | THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] | 9 | |
| LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | ACTIVE MOIETY | D7RD81HE4W | THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] | 9 | |
| GLYCINE | INACTIVE INGREDIENT | TE7660XO1C | THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] | 9 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] | 9 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN (RABBIT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] | 9 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| SALINE NASAL | SODIUM CHLORIDE | ALAINA HEALTHCARE PRIVATE LIMITED | ed30a7f9-7132-42da-9bed-63a9b1c80ab2 | 2026-07-07 | Warnings | 451W47IQ8X |
| The Cell Salt Co. Daily Blend 12 in 1 | CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA | The Cell Salt Company LLC | 55826f59-acf4-7370-e063-6394a90afed7 | 2026-07-01 | Warnings | 451W47IQ8X |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55820ff9-7b4b-2bce-e063-6394a90a8b43 | 2026-06-30 | Warnings | 451W47IQ8X |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55806cb8-cf92-c4e5-e063-6394a90aaa2d | 2026-06-30 | Warnings | 451W47IQ8X |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 5581d8e5-4105-e9da-e063-6394a90a316e | 2026-06-30 | Warnings | 451W47IQ8X |
| Thymoglobulin | ANTI-THYMOCYTE GLOBULIN (RABBIT) | Genzyme Corporation | bbd8ab99-552e-4b81-aca4-6b0c7af8b9ae | 2026-06-24 | Warnings, Adverse reactions | BLA103869 58468-0080-1 58468-0080 58468008001 107047 107050 1e694a66-3d88-498c-ae79-47bc6f1c7b7d bbd8ab99-552e-4b81-aca4-6b0c7af8b9ae D7RD81HE4W |
| MCAS Support | APIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENS | Deseret Biologicals, Inc. | af3d5f8f-6f24-4045-8730-c776ff54bcc4 | 2026-06-24 | Warnings | 451W47IQ8X |
| 0.9% Sodium Chloride Saline Solution | SODIUM CHLORIDE | Yunqi Cosmetics (Shenzhen) Co., Ltd | 546af257-dbd1-11fc-e063-6394a90a8e0a | 2026-06-16 | Warnings | 451W47IQ8X |
| BM BM68 DROPS | ARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | BM Private Limited | 53f9c99a-0f20-0358-e063-6394a90af4e0 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BM68 | ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5448c76a-2ecb-9402-e063-6294a90a6ad7 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 544b66c4-49df-556f-e063-6394a90af3ed | 2026-06-15 | Warnings | 451W47IQ8X |
| Male Support | AGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 29cefc89-3bb6-484e-84ab-116b5827a4c3 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BM68 DROPS | ARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5410ec88-8c65-3b26-e063-6294a90adf07 | 2026-06-12 | Warnings | 451W47IQ8X |
| V HP | ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUR | Energique, Inc. | ea12ca3b-19e0-4d4a-9514-4d28d214e1e7 | 2026-06-12 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 107af8bc-b6af-4b85-8c8a-ea757dcef1da | 2026-06-12 | Adverse reactions | 451W47IQ8X |
| Jacksons Cell Salts DIGESTIVE BALANCE | NAT MUR, NAT PHOS, NAT SULPH | Zettl Health Inc. | 54018d0e-372f-8afc-e063-6394a90aeb15 | 2026-06-11 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.