NDC 13533-702 - PROLASTIN-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
- 13533-702
- Package NDCs from labels
- 13533-702-11
- Manufacturer
- GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA
- Effective date
- 2022-02-25
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| PROLASTIN-C - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA | GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA | 2022-02-25 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13533-702-11 | PROLASTIN-C | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 mL | 1000 mg in 20mL | 25 |
| 13533-702-11 | PROLASTIN-C | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 mL | 1000 mg in 20mL | 25 |
| 13533-702-11 | PROLASTIN-C | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 mL | 1000 mg in 20mL | 25 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Alpha-1-proteinase Inhibitor Human | ACTIVE INGREDIENT | F43I396OIS | PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC] | 13 | |
| Alpha-1-proteinase Inhibitor Human | ACTIVE MOIETY | F43I396OIS | PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC] | 13 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC] | 13 | |
| Sodium Phosphate | INACTIVE INGREDIENT | SE337SVY37 | PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC] | 13 |
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 |
|---|---|---|---|---|---|---|
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 009bef3c-e8ac-46be-b564-a2556adf0081 | 2025-10-31 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Lactated Ringers and Dextrose | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | 237b39fa-916e-4a54-99c8-4ae9ad54f056 | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Normosol-R and Dextrose | DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | ead1fca3-eff4-478f-8a8f-67510f80151a | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 0e089a44-0cee-4804-8f6f-8508508ddb5c | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 189b8ac6-e346-454f-b501-7645590ca4f8 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Cold and Cough 4 Kids | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Hyland's Inc. | e06599ca-fc94-4b2c-829e-f3d4ec866ed6 | 2025-10-29 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 97007188-43fe-416c-a87b-6ccc4d9ae2ec | 2025-10-29 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | ICU Medical Inc. | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | 05f326e6-10e4-4ceb-8a23-f53c592f00b8 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Corporation | 6acc9f96-7088-45a7-b48f-1a861e3467ab | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE | Baxter Healthcare Company | dad7735c-709b-40ea-ab7a-15577e24a966 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| WALMART SALINE | SALINE NASAL (SODIUM CHLORIDE) | WALMART STORES INC | 06906744-49a5-4bab-8539-af2d235df9e8 | 2025-10-28 | Warnings | 451W47IQ8X |
| Saline | NASAL | PUBLIX SUPER MARKETS, INC | 19841567-9511-43d6-ba4e-d1e1bd3481a4 | 2025-10-28 | Warnings | 451W47IQ8X |
| Bacteriostatic Water | WATER | Henry Schein, Inc. | a833502e-a622-4e81-8c58-cef6ccb6c4c9 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Jacksons Cell Salts KALI MUR 6X 5 | KALI MURIATICUM | Zettl Health Inc. | 41ed34d0-94c3-ce79-e063-6294a90a08cb | 2025-10-24 | Warnings | 451W47IQ8X |
| NORMOSOL-M AND DEXTROSE | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE | ICU Medical Inc. | aba60c84-94d9-46d0-bdbb-25e0c4e8cc41 | 2025-10-24 | Warnings, Adverse reactions | 451W47IQ8X |
| miranda castros HEALING FOR INSECT BITES AND STINGS | CALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS | MIRANDA CASTRO'S SHOP, LLC | 1f99d32e-2394-411a-e063-6294a90ac454 | 2025-10-23 | Warnings | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | ICU Medical Inc. | b96eb740-749a-4d3a-ae63-b8e3947cad30 | 2025-10-23 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | Becton Dickinson and Company | cab03cda-4660-4020-a3be-bf86242ff664 | 2025-10-22 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.