Heparin Sodium
- Product NDC
- 0781-3555
- Requested package NDC
- 0781-3555-25
- 11-digit product format
- 007813555
- Labeler code
- 0781
- Product ID
- 0781-3555_2ef18b0f-ccc2-5539-e063-6394a90a2a4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Heparin Sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Sandoz Inc.
- Application
- ANDA202732
- Marketing category
- ANDA
- Marketing start
- 2014-06-12
- Substance
- HEPARIN SODIUM
- Active strength
- 1000 [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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202732-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | 2014-06-12 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | 2014-06-12 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | 2014-06-12 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | 2014-06-12 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | 2014-06-12 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A202732-001 | HEPARIN SODIUM PRESERVATIVE FREE | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | 2014-06-12 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202732-001 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202732-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202732-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202732-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202732-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202732-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202732-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202732-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202732-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202732-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202732-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202732-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202732-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202732-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202732-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202732-001 | AP | 1 | 8072bd15b7f6… |
| 2019-12-13 00:20 UTC | 2019-12 | A202732-001 | AP | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202732-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A202732-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A202732-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A202732-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A202732-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202732-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A202732-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202732-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A202732-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A202732-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202732-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202732-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202732-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202732-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A202732-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A202732-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202732-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A202732-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A202732-001 | AP | 1 | e64feba35796… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A202732-001 | AP | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Heparin Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HEPARIN SODIUM | 1000 [USP'U]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| ZZ45AB24CA | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1c634e53-44d6-cdcd-e063-6294a90a92e9 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0781-3555-10 | Heparin Sodium | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | 4 | |
| 0781-3555-25 | Heparin Sodium | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-3555-10 | ML - Milliliter | 0781-3555 | 4cbf5793-0e0a-47c6-87e4-4da79ac5ec01 | 1 | 2024-10-04 |
| 0781-3555-25 | ML - Milliliter | 0781-3555 | f81d7127-7534-4dd5-959c-34a040b1bd35 | 1 | 2024-10-04 |
DailyMed Dashboard NDC Coverage#
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 | Hepalink USA Inc. | c4c6bc1f-e0c7-fd0d-e053-2995a90abdef | 2025-02-19 | Warnings, Adverse reactions | 202732 ANDA202732 |
| Heparin Sodium | HEPARIN SODIUM | Sandoz Inc. | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 2025-02-19 | Warnings, Adverse reactions | 202732 ANDA202732 0781-3555-25 0781-3555 00781355525 |
| Heparin Sodium | HEPARIN SODIUM | McKesson Corporation dba SKY Packaging | 7f05762a-7527-4796-b21e-68277aec379e | 2025-01-21 | Warnings, Adverse reactions | 202732 ANDA202732 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1362831 | heparin sodium, porcine 10,000 UNT/ML Injectable Solution | PSN | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1361226 | heparin sodium, porcine 1000 UNT/ML Injectable Solution | PSN | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1361574 | heparin sodium, porcine 20,000 UNT/ML Injectable Solution | PSN | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1658647 | heparin sodium, porcine 2000 UNT in 2 ML Injection | PSN | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1361615 | heparin sodium, porcine 5000 UNT/ML Injectable Solution | PSN | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1658647 | 2 ML heparin sodium, porcine 1000 UNT/ML Injection | SCD | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1361226 | heparin sodium, porcine 1000 UNT/ML Injectable Solution | SCD | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1362831 | heparin sodium, porcine 10000 UNT/ML Injectable Solution | SCD | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1361574 | heparin sodium, porcine 20000 UNT/ML Injectable Solution | SCD | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1361615 | heparin sodium, porcine 5000 UNT/ML Injectable Solution | SCD | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1362831 | heparin sodium, porcine 10,000 UNT/ML Injectable Solution | SY | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1361574 | heparin sodium, porcine 20,000 UNT/ML Injectable Solution | SY | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
| 1658647 | heparin sodium, porcine 2000 UNT per 2 ML Injection | SY | 1c634e53-44d6-cdcd-e063-6294a90a92e9 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0781-3555-25 | 00781355525 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3555-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0781-3555-10) | 2024-09-16 | No | No | Current |