Heparin Sodium
- Product NDC
- 63323-459
- 11-digit product format
- 633230459
- Labeler code
- 63323
- Product ID
- 63323-459_529104c9-6154-4428-953d-5546875f32e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HEPARIN SODIUM
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA017029
- Marketing category
- NDA
- Marketing start
- 1972-02-22
- Substance
- HEPARIN SODIUM
- Active strength
- 10000 [USP'U]/mL
- Pharmacologic classes
- Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Heparin Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HEPARIN SODIUM | 10000 [USP'U]/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | ZZ45AB24CA |
| Rxcui | 1361226, 1361574, 1361615, 1362831, 1658634, 1658647 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fac74f96-3910-44b9-8551-036880fbb1fb | Product name | 1 | 20260108 |
| 0a18eae4-4259-42db-86b6-915f66e83b06 | Product name | 1 | 20250729 |
| 2c999b01-2a13-4eff-8eb4-00b87316ef79 | Product name | 1 | 20231116 |
| 05193eb6-d122-ab0b-603b-d9dd92599836 | Product name | 2 | 20210204 |
| 2e5437ef-ff80-c9c2-2f66-5b7c771080be | Product name | 9 | 20180201 |
| ae28a785-50d8-477d-a268-dffdfdd7504b | Product name | 1 | 20150305 |
| 0c878822-66ca-456d-c17d-0894b04fa473 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-459-09 | Heparin Sodium | 4 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 4 | 13 | |
| 63323-459-09 | Heparin Sodium | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 13 | |
| 63323-459-04 | Heparin Sodium | 4 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 4 | 6 | |
| 63323-459-14 | Heparin Sodium | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-459-09 | ML - Milliliter | 63323-459 | bbc31a4f-721f-4897-853b-f9f75c55081f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HEPARIN SODIUM | ACTIVE INGREDIENT | ZZ45AB24CA | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 | |
| HEPARIN | ACTIVE MOIETY | T2410KM04A | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-459 | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 12 | Current NDC, Legacy NDC, 2 package rows | 20241017_d55b4a63-0c04-4874-b74f-9e9b9e8b008c.zip |
| 63323-459 | HEPARIN SODIUM (HEPARIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220129_2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1362831 | heparin sodium, porcine 10,000 UNT/ML Injectable Solution | PSN | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1361226 | heparin sodium, porcine 1000 UNT/ML Injectable Solution | PSN | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1361574 | heparin sodium, porcine 20,000 UNT/ML Injectable Solution | PSN | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1658647 | heparin sodium, porcine 2000 UNT in 2 ML Injection | PSN | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1658634 | heparin sodium, porcine 5000 UNT in 0.5 mL Injection | PSN | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1361615 | heparin sodium, porcine 5000 UNT/ML Injectable Solution | PSN | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1658634 | 0.5 ML heparin sodium, porcine 10000 UNT/ML Injection | SCD | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1658647 | 2 ML heparin sodium, porcine 1000 UNT/ML Injection | SCD | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1361226 | heparin sodium, porcine 1000 UNT/ML Injectable Solution | SCD | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1362831 | heparin sodium, porcine 10000 UNT/ML Injectable Solution | SCD | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1361574 | heparin sodium, porcine 20000 UNT/ML Injectable Solution | SCD | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1361615 | heparin sodium, porcine 5000 UNT/ML Injectable Solution | SCD | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1362831 | heparin sodium, porcine 10,000 UNT/ML Injectable Solution | SY | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1361574 | heparin sodium, porcine 20,000 UNT/ML Injectable Solution | SY | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1658647 | heparin sodium, porcine 2000 UNT per 2 ML Injection | SY | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1658634 | heparin sodium, porcine 5000 UNT per 0.5 ML Injection | SY | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 13 |
| 1362831 | heparin sodium, porcine 10,000 UNT/ML Injectable Solution | PSN | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1361226 | heparin sodium, porcine 1000 UNT/ML Injectable Solution | PSN | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1361574 | heparin sodium, porcine 20,000 UNT/ML Injectable Solution | PSN | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1658634 | heparin sodium, porcine 5000 UNT in 0.5 mL Injection | PSN | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1361615 | heparin sodium, porcine 5000 UNT/ML Injectable Solution | PSN | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1658634 | 0.5 ML heparin sodium, porcine 10000 UNT/ML Injection | SCD | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1361226 | heparin sodium, porcine 1000 UNT/ML Injectable Solution | SCD | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1362831 | heparin sodium, porcine 10000 UNT/ML Injectable Solution | SCD | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1361574 | heparin sodium, porcine 20000 UNT/ML Injectable Solution | SCD | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1361615 | heparin sodium, porcine 5000 UNT/ML Injectable Solution | SCD | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1362831 | heparin sodium, porcine 10,000 UNT/ML Injectable Solution | SY | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1361574 | heparin sodium, porcine 20,000 UNT/ML Injectable Solution | SY | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
| 1658634 | heparin sodium, porcine 5000 UNT per 0.5 ML Injection | SY | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-459-04 | 63323045904 | 4 mL in 1 VIAL, MULTI-DOSE | 4 ml | Historical | ||||
| 63323-459-09 | 63323045909 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-459-09) > 4 mL in 1 VIAL, MULTI-DOSE | 2011-03-31 | 0000-00-00 | No | No | Current | |
| 63323-459-14 | 63323045914 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-459-14) > 4 mL in 1 VIAL, MULTI-DOSE (63323-459-04) | 2019-11-04 | 0000-00-00 | No | No | Current |