Enoxaparin Sodium
- Product NDC
- 60505-0791
- Requested package NDC
- 60505-0791-4
- 11-digit product format
- 605050791
- Labeler code
- 60505
- Product ID
- 60505-0791_86fde550-ac79-87d9-be58-6d10e4b74e77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- enoxaparin sodium
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Apotex Corp.
- Application
- ANDA078990
- Marketing category
- ANDA
- Marketing start
- 2019-01-31
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | 60505-0791 | 60505-0791-4 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-0791-0 | ML - Milliliter | 60505-0791 | c9afa9a6-aa3d-4f8b-b226-5857061566fd | 1 | 2019-02-13 |
| 60505-0791-4 | ML - Milliliter | 60505-0791 | 9b3af227-730a-4f15-b5ab-43420f47104c | 1 | 2019-02-13 |
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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60505-0791-4 | 60505079104 | 10 SYRINGE in 1 CARTON (60505-0791-4) > .3 mL in 1 SYRINGE | 10 syringe | 2019-01-31 | 0000-00-00 | No | No | Current |