ENOXAPARIN SODIUM
- Product NDC
- 68083-634
- Requested package NDC
- 68083-634-10
- 11-digit product format
- 680830634
- Labeler code
- 68083
- Product ID
- 68083-634_24d882c6-ad8c-488a-a3ab-810f5feb4025
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ENOXAPARIN SODIUM
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA078990
- Marketing category
- ANDA
- Marketing start
- 2023-07-11
- Substance
- ENOXAPARIN SODIUM
- Active strength
- 30 mg/.3mL
- Pharmacologic classes
- Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078990-001 | AP |
| A078990-002 | AP |
| A078990-003 | AP |
| A078990-004 | AP |
| A078990-005 | AP |
| A078990-006 | AP |
| A078990-007 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078990-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-005 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-006 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-007 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-005 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-006 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-007 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-005 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-006 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-007 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-005 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-006 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-007 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-004 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-005 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-006 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-007 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-004 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-005 | AP | 1 | 03ed91905a0d… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ENOXAPARIN SODIUM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ENOXAPARIN SODIUM | 30 mg/.3mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8NZ41MIK1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 65025e0d-eb54-4c4e-bd14-f294ce038902 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 33a7d2c8-f5cf-4d97-8510-92190c5e0f12 | Product name | 7 | 20240606 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68083-634-10 | ENOXAPARIN SODIUM | 0.3 mL in 1 SYRINGE | INJECTION | 0.3 | 2 | |
| 68083-634-10 | ENOXAPARIN SODIUM | 10 in 1 CARTON | INJECTION | 10 | 2 |
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 |
|---|---|---|---|---|---|---|
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Cardinal Health 107, LLC | 45a66675-b159-42b8-9f18-ff80f28e1503 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Fresenius Kabi USA, LLC | c3be543e-8aff-4311-bf77-e7a5a814ca6f | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 |
| ENOXAPARIN SODIUM | ENOXAPARIN SODIUM | Gland Pharma Limited | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 68083-634-10 68083-634 68083063410 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Civica, Inc. | b4728749-8453-4f07-9fbc-a1f3e9d2708b | 2025-10-04 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Fresenius Kabi USA, LLC | a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Sagent Pharmaceuticals | 419a3566-4f67-4c8d-86e5-c00c7ec429e1 | 2023-08-28 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 854248 | enoxaparin sodium 100 MG in 1 ML Prefilled Syringe | PSN | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854245 | enoxaparin sodium 120 MG in 0.8 ML Prefilled Syringe | PSN | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854252 | enoxaparin sodium 150 MG in 1 ML Prefilled Syringe | PSN | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854228 | enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe | PSN | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854235 | enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe | PSN | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854238 | enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe | PSN | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854241 | enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe | PSN | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854228 | 0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe | SCD | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854235 | 0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe | SCD | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854238 | 0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe | SCD | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854241 | 0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe | SCD | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854245 | 0.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe | SCD | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854248 | 1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe | SCD | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854252 | 1 ML enoxaparin sodium 150 MG/ML Prefilled Syringe | SCD | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854228 | 0.3 ML ENX sodium 100 MG/ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854235 | 0.4 ML ENX sodium 100 MG/ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854238 | 0.6 ML ENX sodium 100 MG/ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854241 | 0.8 ML ENX sodium 100 MG/ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854245 | 0.8 ML ENX sodium 150 MG/ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854248 | 1 ML ENX sodium 100 MG/ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854252 | 1 ML ENX sodium 150 MG/ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854252 | enoxaparin 150 MG per 1 ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854248 | enoxaparin sodium 100 MG per 1 ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854245 | enoxaparin sodium 120 MG per 0.8 ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854228 | enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854235 | enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854238 | enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
| 854241 | enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe | SY | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68083-634-10 | 68083063410 | 10 SYRINGE in 1 CARTON (68083-634-10) / .3 mL in 1 SYRINGE | 10 syringe | 2023-07-11 | No | No | Current |