Heparin Sodium
- Product NDC
- 63323-543
- 11-digit product format
- 633230543
- Labeler code
- 63323
- Product ID
- 63323-543_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
- 5000 [USP'U]/.5mL
- Pharmacologic classes
- Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63323-543 | 63323-543-02 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017029-001 | HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N017029-002 | HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017029-003 | HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N017029-004 | HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N017029-010 | HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1986-04-28 |
| N017029-013 | HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 |
| N017029-014 | HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 |
| N017029-015 | HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 |
| N017029-016 | HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 |
| N017029-019 | HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2010-11-22 |
| N017029-020 | HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2011-03-31 | |
| N017029-021 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 40 UNITS/ML | INJECTABLE / INJECTION | RLD | 2017-08-24 | |
| N017029-022 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 50 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | |
| N017029-023 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 100 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | |
| N017029-024 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | 50 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | |
| N017029-025 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | 100 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N017029-001 | AP |
| N017029-003 | AP |
| N017029-004 | AP |
| N017029-010 | AP |
| N017029-013 | AP |
| N017029-014 | AP |
| N017029-015 | AP |
| N017029-016 | AP |
| N017029-019 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N017029-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017029-002 | HEPARIN SODIUM | 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017029-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017029-004 | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017029-010 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1986-04-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-013 | HEPARIN SODIUM IN PLASTIC CONTAINER | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-014 | HEPARIN SODIUM IN PLASTIC CONTAINER | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-015 | HEPARIN SODIUM IN PLASTIC CONTAINER | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-016 | HEPARIN SODIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-019 | HEPARIN SODIUM PRESERVATIVE FREE | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2010-11-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-020 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2011-03-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017029-021 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% | 40 UNITS/ML | INJECTABLE / INJECTION | RLD | 2017-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017029-022 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | 50 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017029-023 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | 100 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017029-024 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | 50 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017029-025 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | 100 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-002 | HEPARIN SODIUM | 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017029-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-004 | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-010 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1986-04-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-013 | HEPARIN SODIUM IN PLASTIC CONTAINER | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-014 | HEPARIN SODIUM IN PLASTIC CONTAINER | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-015 | HEPARIN SODIUM IN PLASTIC CONTAINER | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-016 | HEPARIN SODIUM IN PLASTIC CONTAINER | 20,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-019 | HEPARIN SODIUM PRESERVATIVE FREE | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 2010-11-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-020 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2011-03-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-021 | HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% | 40 UNITS/ML | INJECTABLE / INJECTION | RLD | 2017-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-022 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | 50 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-023 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | 100 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-024 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | 50 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-025 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | 100 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2017-08-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-002 | HEPARIN SODIUM | 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-004 | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-010 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1986-04-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-013 | HEPARIN SODIUM IN PLASTIC CONTAINER | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-014 | HEPARIN SODIUM IN PLASTIC CONTAINER | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-015 | HEPARIN SODIUM IN PLASTIC CONTAINER | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1985-12-05 | 31067a03dcf5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N017029-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-010 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-013 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-014 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-015 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-016 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017029-019 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-010 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-013 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-014 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-015 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-016 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017029-019 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-010 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-013 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-014 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-015 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-016 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017029-019 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N017029-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017029-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017029-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017029-010 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017029-013 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017029-014 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017029-015 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017029-016 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017029-019 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017029-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017029-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017029-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017029-010 | AP | 1 | fd3edfee7708… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Heparin Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HEPARIN SODIUM | 5000 [USP'U]/.5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| ZZ45AB24CA | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d55b4a63-0c04-4874-b74f-9e9b9e8b008c | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 63323-543-02 | Heparin Sodium | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 13 | |
| 63323-543-02 | Heparin Sodium | 0.5 mL in 1 VIAL | INJECTION, SOLUTION | 0.5 | 13 | |
| 63323-543-03 | Heparin Sodium | 0.5 mL in 1 VIAL | INJECTION, SOLUTION | 0.5 | 6 | |
| 63323-543-13 | 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 |
|---|---|---|---|---|---|
| 63323-543-02 | ML - Milliliter | 63323-543 | 250ff86d-60df-461e-84c2-543761397714 | 1 | 2012-07-24 |
| 63323-543-03 | ML - Milliliter | 63323-543 | 8f0a4f8d-e690-4679-8f30-6698ed2c6d4c | 1 | 2020-09-14 |
| 63323-543-13 | ML - Milliliter | 63323-543 | d255c3d2-02f6-4e4f-96c8-16ed7c52d714 | 1 | 2020-09-14 |
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 |
|---|---|---|---|---|
| 63323-543 | HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 12 | Current NDC, Legacy NDC, 2 package rows | 20241017_d55b4a63-0c04-4874-b74f-9e9b9e8b008c.zip |
| 63323-543 | 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 |
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 |
|---|---|---|---|---|---|---|
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | f67eea4e-80ff-48da-8b04-8addc5cd31d1 | 2026-05-12 | Warnings, Adverse reactions | 017029 NDA017029 |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 2026-04-30 | Warnings, Adverse reactions | 017029 NDA017029 63323-543 |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 2025-11-28 | Warnings, Adverse reactions | 017029 NDA017029 63323-543 |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | ed937dd2-8fab-4875-a1e8-627b71ccb7fb | 2025-11-27 | Warnings, Adverse reactions | 017029 NDA017029 |
| Heparin Sodium | HEPARIN SODIUM | Henry Schein, Inc. | 3a998729-c912-4e21-8e49-d1e72ba6fe9e | 2025-10-31 | Warnings, Adverse reactions | 017029 NDA017029 |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | 239b4816-6a55-451b-bf40-e611be07d12f | 2025-10-14 | Warnings, Adverse reactions | 017029 NDA017029 |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | 9207cef5-4cec-41e7-a351-29ba726feb44 | 2025-08-15 | Warnings, Adverse reactions | 017029 NDA017029 |
| Heparin Sodium | HEPARIN SODIUM | Phlow Corporation | cece935c-1c0a-4949-b023-d6df3d53fbfa | 2024-05-16 | Warnings, Adverse reactions | 017029 NDA017029 |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | cb1c1e7a-c9ca-4a07-8833-e45ce436d287 | 2024-04-30 | Warnings, Adverse reactions | 017029 NDA017029 |
| HEPARIN SODIUM | HEPARIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | 971505d4-f78c-6f5d-e053-2995a90a00e0 | 2024-01-29 | Warnings, Adverse reactions | 017029 NDA017029 |
| HEPARIN SODIUM IN SODIUM CHLORIDE | HEPARIN SODIUM IN SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c72b193e-0687-e002-e053-2995a90a7182 | 2024-01-27 | Warnings, Adverse reactions | 017029 NDA017029 |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | a120bdfd-21e1-4024-82a7-13cfeed290c1 | 2024-01-05 | Warnings, Adverse reactions | 017029 NDA017029 |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | 3facd525-b9ad-46d0-b63e-f13a5f6d591d | 2021-09-01 | Warnings, Adverse reactions | 017029 NDA017029 |
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 |
| 1658634 | heparin sodium, porcine 5000 UNT in 0.5 mL Injection | PSN | f67eea4e-80ff-48da-8b04-8addc5cd31d1 | 5 |
| 1361615 | heparin sodium, porcine 5000 UNT/ML Injectable Solution | PSN | f67eea4e-80ff-48da-8b04-8addc5cd31d1 | 5 |
| 1658634 | 0.5 ML heparin sodium, porcine 10000 UNT/ML Injection | SCD | f67eea4e-80ff-48da-8b04-8addc5cd31d1 | 5 |
| 1361615 | heparin sodium, porcine 5000 UNT/ML Injectable Solution | SCD | f67eea4e-80ff-48da-8b04-8addc5cd31d1 | 5 |
| 1658634 | heparin sodium, porcine 5000 UNT per 0.5 ML Injection | SY | f67eea4e-80ff-48da-8b04-8addc5cd31d1 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-543-02 | 63323054302 | 25 VIAL in 1 TRAY (63323-543-02) > .5 mL in 1 VIAL | 25 vial | 2010-11-22 | 0000-00-00 | No | No | Current |
| 63323-543-03 | 63323054303 | 0.5 mL in 1 VIAL | 0.5 ml | Historical | ||||
| 63323-543-13 | 63323054313 | 25 VIAL in 1 TRAY (63323-543-13) / .5 mL in 1 VIAL (63323-543-03) | 25 vial | 2019-11-04 | 0000-00-00 | No | No | Current |