Heparin Sodium
- Product NDC
- 63323-522
- 11-digit product format
- 633230522
- Labeler code
- 63323
- Product ID
- 63323-522_c656be9f-793a-4d25-b563-539dce89cbc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HEPARIN SODIUM
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA017029
- Marketing category
- NDA
- Marketing start
- 2017-08-24
- Substance
- HEPARIN SODIUM
- Active strength
- 5000 [USP'U]/100mL
- 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 table| Ingredient | Strength |
|---|
| HEPARIN SODIUM | 5000 [USP'U]/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZZ45AB24CA |
| Rxcui | 1658717, 1659195 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-522-01 | Heparin Sodium | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | | 8 |
| 63323-522-77 | Heparin Sodium | 24 in 1 CASE | INJECTION, SOLUTION | 24 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-522 | HEPARIN SODIUM (HEPARIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240503_cb1c1e7a-c9ca-4a07-8833-e45ce436d287.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1658717 | heparin sodium, porcine 25,000 UNT in 250 ML Injection | PSN | cb1c1e7a-c9ca-4a07-8833-e45ce436d287 | 8 |
| 1659195 | heparin sodium, porcine 25,000 UNT in 500 ML Injection | PSN | cb1c1e7a-c9ca-4a07-8833-e45ce436d287 | 8 |
| 1658717 | 250 ML heparin sodium, porcine 100 UNT/ML Injection | SCD | cb1c1e7a-c9ca-4a07-8833-e45ce436d287 | 8 |
| 1659195 | 500 ML heparin sodium, porcine 50 UNT/ML Injection | SCD | cb1c1e7a-c9ca-4a07-8833-e45ce436d287 | 8 |
| 1658717 | heparin sodium, porcine 25,000 UNT per 250 ML Injection | SY | cb1c1e7a-c9ca-4a07-8833-e45ce436d287 | 8 |
| 1659195 | heparin sodium, porcine 25,000 UNT per 500 ML Injection | SY | cb1c1e7a-c9ca-4a07-8833-e45ce436d287 | 8 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-522-01 | 63323052201 | 500 mL in 1 BAG | 500 ml | | | | | Historical |
| 63323-522-77 | 63323052277 | 24 BAG in 1 CASE (63323-522-77) / 500 mL in 1 BAG (63323-522-01) | 24 bag | 2017-08-24 | 0000-00-00 | No | No | Current |