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 |
|---|---|---|---|---|---|---|
| Rite Aid Eye Wash | PURIFIED WATER | Rite Aid | 28a18e04-d735-a511-e063-6394a90af6bb | 2025-12-30 | Warnings | 059QF0KO0R |
| OCUFRESH | WATER | Optics Laboratory Inc. | b8e477a9-66b9-496b-92fb-3d4bbd7b36b5 | 2025-12-29 | Warnings | 059QF0KO0R |
| Kollourion Eyesalve Eyewash | PURIFIED WATER 98.3% | Miracle Eye Pharmaceuticals | b56d2ab9-169b-b490-e053-2a95a90a80b3 | 2025-12-28 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | ProPharma Distribution | 386a0a2f-4ff7-f128-e063-6294a90a7d4d | 2025-12-18 | Warnings, Adverse reactions | 059QF0KO0R |
| Firstep Firstflush | EYEWASH | Encon Safety Products, Inc. | a44beb26-79ae-98bd-e053-2995a90a9b74 | 2025-12-09 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | beda35c3-9a8b-47ad-e053-2995a90a7b1b | 2025-11-24 | Warnings | 059QF0KO0R |
| Easy Care First Aid Eyewash | WATER | Tender Corporation | a070aac8-e6d2-ef10-e053-2a95a90aa5b1 | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | e07a064b-f680-405c-bbcd-24fac430951e | 2025-11-24 | Warnings | 059QF0KO0R |
| ULINE Eyewash | EYEWASH | Niagara Pharmaceuticals Inc. | 2d7f22d2-320b-6af1-e063-6294a90addc6 | 2025-11-24 | Warnings | 059QF0KO0R |
| Pur-Wash | EYEWASH | Niagara Pharmaceuticals, Inc. | 0d43b1c1-2699-37f1-e054-00144ff88e88 | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 777e1559-786f-8d54-e053-2991aa0aa98d | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 7289103a-5cbf-42f4-8848-e827149a43ca | 2025-11-24 | Warnings | 059QF0KO0R |
| Eyewash Additive Concentrate | WATER AND PROPYLENE GLYCOL | Haws Corporation | dd168403-398c-41ff-b1df-d93e4ff39de3 | 2025-11-20 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | fd823bef-c14c-4708-a18a-8aaa8470412f | 2025-11-18 | Warnings, Adverse reactions | 059QF0KO0R |
| Eyesaline Eyewash Concentrate | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 3765c251-eb14-d60f-e063-6294a90a6a4d | 2025-11-12 | Warnings | 059QF0KO0R |
| Eyesaline Emergency Eyewash | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 37f244fd-c02f-e66a-e063-6394a90aed81 | 2025-11-12 | Warnings | 059QF0KO0R |
| STERILE WATER | WATER | Henry Schein, Inc. | f4087143-9868-4308-b96c-43657ee8ec28 | 2025-11-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Bacteriostatic Water | BACTERIOSTATIC WATER | ProPharma Distribution | 42c6938e-f747-ae13-e063-6294a90a59a3 | 2025-11-04 | Warnings, Adverse reactions | 059QF0KO0R |
| Aminosyn II | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE | ICU Medical Inc. | 5b426208-f090-4650-86c3-89040ba45c2d | 2025-11-02 | Boxed warning, Warnings, Adverse reactions | TE7660XO1C |
| Sterile Water | WATER | ICU Medical Inc. | aab10f03-26ae-4dbc-a481-ef025e48b405 | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.