NDC 13533-800-41 - Gamunex-C
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
- 13533-800
- Requested NDC
- 13533-800-41
- Package NDCs from labels
- 13533-800-13, 13533-800-12, 13533-800-16, 13533-800-15, 13533-800-21, 13533-800-20, 13533-800-72, 13533-800-71, 13533-800-25, 13533-800-24, 13533-800-41, 13533-800-40
- Manufacturer
- GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | GRIFOLS BIOLOGICALS LLC
- Effective date
- 2022-04-29
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Glycine - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | GRIFOLS BIOLOGICALS LLC | GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | GRIFOLS BIOLOGICALS LLC | 2022-04-29 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13533-800-12 | Gamunex-C | 1 in 1 CARTON | INJECTION | 1 | 37 | |
| 13533-800-13 | Gamunex-C | 10 mL in 1 VIAL, GLASS | INJECTION | 10 | 37 | |
| 13533-800-15 | Gamunex-C | 1 in 1 CARTON | INJECTION | 1 | 37 | |
| 13533-800-16 | Gamunex-C | 25 mL in 1 VIAL, GLASS | INJECTION | 25 | 37 | |
| 13533-800-20 | Gamunex-C | 1 in 1 CARTON | INJECTION | 1 | 37 | |
| 13533-800-21 | Gamunex-C | 50 mL in 1 VIAL, GLASS | INJECTION | 50 | 37 | |
| 13533-800-24 | Gamunex-C | 1 in 1 CARTON | INJECTION | 1 | 37 | |
| 13533-800-25 | Gamunex-C | 200 mL in 1 VIAL, GLASS | INJECTION | 200 | 37 | |
| 13533-800-40 | Gamunex-C | 1 in 1 CARTON | INJECTION | 1 | 37 | |
| 13533-800-41 | Gamunex-C | 400 mL in 1 VIAL, GLASS | INJECTION | 400 | 37 | |
| 13533-800-71 | Gamunex-C | 1 in 1 CARTON | INJECTION | 1 | 37 | |
| 13533-800-72 | Gamunex-C | 100 mL in 1 VIAL, GLASS | INJECTION | 100 | 37 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Human Immunoglobulin G | ACTIVE INGREDIENT | 66Y330CJHS | GAMUNEX-C (IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% CAPRYLATE CHROMATOGRAPHY PURIFIED) INJECTION [GRIFOLS USA, LLC] | 24 | |
| Human Immunoglobulin G | ACTIVE MOIETY | 66Y330CJHS | GAMUNEX-C (IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% CAPRYLATE CHROMATOGRAPHY PURIFIED) INJECTION [GRIFOLS USA, LLC] | 24 | |
| Glycine | INACTIVE INGREDIENT | TE7660XO1C | GAMUNEX-C (IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% CAPRYLATE CHROMATOGRAPHY PURIFIED) INJECTION [GRIFOLS USA, LLC] | 24 |
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 |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | ICU Medical Inc. | e3484bc6-ed7f-43ef-9d49-c131a8dff2dd | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Bacteriostatic Water | WATER | Henry Schein, Inc. | a833502e-a622-4e81-8c58-cef6ccb6c4c9 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Becton Dickinson and Company | cab03cda-4660-4020-a3be-bf86242ff664 | 2025-10-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Glycine | GLYCINE | ICU Medical Inc. | c10a4657-cf64-4a71-a247-363dd58993bc | 2025-10-21 | Warnings, Adverse reactions | TE7660XO1C |
| Aminosyn-PF | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE | ICU Medical Inc. | 2d212e10-7e08-4aeb-b63f-dcc927897769 | 2025-10-17 | Warnings, Adverse reactions | TE7660XO1C |
| Aminosyn-PF | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE | ICU Medical Inc. | 46e74ce4-cd7e-437f-bf54-ca9b98eb2663 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | TE7660XO1C |
| Xpect Eyewash | EYEWASH | Cintas Corporation | 1d69365d-662b-4248-8fa9-1629451b549a | 2025-09-30 | Warnings | 059QF0KO0R |
| CheBoho TEA TREE ACNE | CHEBOHO TEA TREE ACNE | Opalshi(Guangzhou)E-commerce Co. Ltd. | 3fc4cf84-b2da-c593-e063-6394a90abc5c | 2025-09-27 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | ProPharma Distribution | 3f2ae880-852f-b45d-e063-6394a90aa1cc | 2025-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| Perikabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | c2eb5522-8572-45f4-869d-42f9fd251bb6 | 2025-09-15 | Warnings, Adverse reactions | TE7660XO1C |
| Kabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | afeb4837-a759-4484-a76e-e04611c459e7 | 2025-09-11 | Warnings, Adverse reactions | TE7660XO1C |
| Medi-First First Aid Eye Wash | PURIFIED WATER | Unifirst First Aid Corporation | dcd7fe56-ff5c-4c8d-a415-6e363d7e53f4 | 2025-09-08 | Warnings | 059QF0KO0R |
| Green Guard First Aid Eye Wash | WATER | Unifirst First Aid Corporation | a4ba5526-b4e2-4bcc-9127-aa22ebf5017f | 2025-09-08 | Warnings | 059QF0KO0R |
| Medi-First Plus First Aid Eye Wash | WATER | Unifirst First Aid Corporation | d7ea80ca-b4a0-4476-8b50-b3425c6d456a | 2025-09-08 | Warnings | 059QF0KO0R |
| ECOLAB Eye Wash | PURIFIED WATER | ECOLAB Food Safety Specialties, Inc. | 4bcfa21a-791e-4d04-e054-00144ff88e88 | 2025-09-08 | Warnings | 059QF0KO0R |
| Physicians Care Eyewash | EYEWASH | Acme United Corporation | 3e239b12-9a75-339d-e063-6294a90a72ae | 2025-09-06 | Warnings | 059QF0KO0R |
| Sterile Water | WATER INJECTION | Henry Schein, Inc. | 3501952b-b556-4d5e-b81b-5c35ff87b475 | 2025-08-28 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | STERILE WATER | Nephron Pharmaceuticals Corporation | bc04a883-babc-87a6-e053-2995a90a3dfd | 2025-07-11 | Warnings, Adverse reactions | 059QF0KO0R |
| Plaque identifying | PLAQUE IDENTIFYING | Shenzhen Yagao Technology Co., Ltd. | 37eeb656-22f1-7372-e063-6394a90ad041 | 2025-06-19 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.