Heparin Sodium
- Product NDC
- 63323-519
- 11-digit product format
- 633230519
- Labeler code
- 63323
- Product ID
- 63323-519_3bbbe74a-1246-41a6-9fc3-ca0230529b40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Heparin Sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA212441
- Marketing category
- ANDA
- Marketing start
- 2020-07-24
- Substance
- HEPARIN SODIUM
- Active strength
- 200 [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 | 200 [USP'U]/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZZ45AB24CA |
| Rxcui | 1658690, 1658692 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-519-01 | Heparin Sodium | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | | 6 |
| 63323-519-02 | Heparin Sodium | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | | 6 |
| 63323-519-10 | Heparin Sodium | 12 in 1 CASE | INJECTION, SOLUTION | 12 | | 6 |
| 63323-519-77 | Heparin Sodium | 24 in 1 CASE | INJECTION, SOLUTION | 24 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-519 | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240502_25b0ba06-3274-4a3f-8c39-42d13764ecdf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-519-01 | 63323051901 | 1000 mL in 1 BAG | 1000 ml | | | | | Historical |
| 63323-519-02 | 63323051902 | 500 mL in 1 BAG | 500 ml | | | | | Historical |
| 63323-519-10 | 63323051910 | 12 BAG in 1 CASE (63323-519-10) / 1000 mL in 1 BAG (63323-519-01) | 12 bag | 2020-07-24 | 0000-00-00 | No | No | Current |
| 63323-519-77 | 63323051977 | 24 BAG in 1 CASE (63323-519-77) / 500 mL in 1 BAG (63323-519-02) | 24 bag | 2020-07-24 | 0000-00-00 | No | No | Current |