NDC 63323-229-01 - Protamine Sulfate
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
- 63323-229
- Requested NDC
- 63323-229-01
- Package NDCs from labels
- 63323-229-01, 63323-229-05, 63323-229-30, 63323-229-21, 63323-229-15, 63323-229-35, 63323-229-26, 63323-229-41, 63323-229-94, 63323-229-95
- Manufacturer
- Fresenius Kabi USA, LLC
- Effective date
- 2025-02-05
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Protamine Sulfate - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2025-02-05 | HUMAN PRESCRIPTION DRUG LABEL |
| Protamine Sulfate - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2024-03-18 | HUMAN PRESCRIPTION DRUG LABEL |
| PROTAMINE SULFATE - HF Acquisition Co LLC, DBA HealthFirst | HF Acquisition Co LLC, DBA HealthFirst | 2024-01-22 | HUMAN PRESCRIPTION DRUG LABEL |
| Protamine Sulfate - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2024-01-18 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-229-01 | Protamine Sulfate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 6 | |
| 63323-229-05 | Protamine Sulfate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 6 | |
| 63323-229-30 | Protamine Sulfate | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 6 | |
| 63323-229-30 | Protamine Sulfate | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | 6 | |
| 63323-229-41 | Protamine Sulfate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 5 | |
| 63323-229-94 | Protamine Sulfate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 5 | |
| 63323-229-95 | Protamine Sulfate | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 5 | |
| 63323-229-95 | Protamine Sulfate | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | 5 | |
| 63323-229-15 | Protamine Sulfate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 4 | |
| 63323-229-21 | Protamine Sulfate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 4 | |
| 63323-229-26 | Protamine Sulfate | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 4 | |
| 63323-229-26 | Protamine Sulfate | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | 4 | |
| 63323-229-35 | Protamine Sulfate | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 4 | |
| 63323-229-35 | Protamine Sulfate | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-229 | PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250214_e1964129-33f4-4e4e-86e3-8e6a4e65bd83.zip |
| 63323-229 | PROTAMINE SULFATE (PROTAMINE SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240208_8df0a819-9e1a-44ce-97a6-3ea82c867d44.zip |
| 63323-229 | PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240402_7a31fc4c-579f-45cc-9559-39cfad9a57b3.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-229-01 | ML - Milliliter | 63323-229 | b248cdf3-93bc-4a84-89e5-acea106e1a12 | 1 | 2024-10-04 |
| 63323-229-05 | ML - Milliliter | 63323-229 | 032fd5ba-1f3c-4e1d-81b9-3705c5841b05 | 1 | 2013-02-13 |
| 63323-229-15 | ML - Milliliter | 63323-229 | 2b208c91-45ce-470d-b2a9-437acb3c8b34 | 1 | 2014-06-03 |
| 63323-229-21 | ML - Milliliter | 63323-229 | 64344195-578b-4a40-87c9-ef9de67820bf | 1 | 2019-08-06 |
| 63323-229-30 | ML - Milliliter | 63323-229 | 5ea5d8d6-1de7-4af5-8c1b-e0894a56e102 | 1 | 2013-02-13 |
| 63323-229-35 | ML - Milliliter | 63323-229 | 40a33f29-25b5-4fda-8cf5-4d72172bfde5 | 1 | 2014-06-03 |
| 63323-229-41 | ML - Milliliter | 63323-229 | 67a8c4b7-7114-4679-865f-5d31482ba3f3 | 1 | 2019-10-07 |
| 63323-229-94 | ML - Milliliter | 63323-229 | 9bb4f4fa-de32-40f2-84d9-2d9bb18aefa4 | 1 | 2014-07-02 |
| 63323-229-95 | ML - Milliliter | 63323-229 | 2b1c90ae-0261-4707-93c4-ade581e81109 | 1 | 2014-07-02 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| 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 | 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 |
| 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 |
| 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 |
| Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g) | NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE) | Reedfresh Co., LTD | 55d703ca-ff9d-0dbc-e063-6294a90ab6b1 | 2026-07-05 | Warnings | 059QF0KO0R |
| Eyesaline Eyewash Concentrate | PURIFIED WATER | Protective Industrial Products, Inc. | 558e5926-9027-d3f6-e063-6294a90ab121 | 2026-07-02 | Warnings | 059QF0KO0R |
| Fendall 2000 Pure Flow | PURIFIED WATER | Protective Industrial Products, Inc. | 55a1d07e-0006-0c75-e063-6394a90a7acc | 2026-07-02 | Warnings | 059QF0KO0R |
| Fendall 1000 Pure Flow | PURIFIED WATER | Protective Industrial Products, Inc. | 55a2f4da-bb1e-8ead-e063-6394a90af72e | 2026-07-02 | Warnings | 059QF0KO0R |
| Sterile Eyesaline Eyewash | STERILE EYESALINE EYEWASH | Protective Industrial Products, Inc. | 55a290e8-8310-8be4-e063-6394a90abdce | 2026-07-02 | Warnings | 059QF0KO0R |
| Eyesaline Emergency Eyewash | PURIFIED WATER | Protective Industrial Products, Inc. | 55a261c2-725d-6765-e063-6294a90a3260 | 2026-07-02 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.