Calcium Gluconate
- Product NDC
- 52584-360
- Requested package NDC
- 52584-360-03
- 11-digit product format
- 525840360
- Labeler code
- 52584
- Product ID
- 52584-360_247dc1e8-daa7-40ac-a7ec-335b62cf6d86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcium Gluconate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- NDA208418
- Marketing category
- NDA
- Marketing start
- 2018-02-12
- Marketing end
- 2024-03-31
- Substance
- CALCIUM GLUCONATE MONOHYDRATE
- Active strength
- 98 mg/mL
- Pharmacologic classes
- Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 52584-360 | 52584-360-03 | D | Discontinued by firm | 2026-08-17 |
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 |
|---|---|---|---|---|---|---|---|
| N208418-001 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 |
| N208418-002 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 |
| N208418-003 | CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 |
| N208418-004 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 1GM/50ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2021-06-17 | |
| N208418-005 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 2GM/100ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2021-06-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N208418-001 | AP |
| N208418-002 | AP |
| N208418-003 | AP |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208418-004 | 10130646 | 2037-07-25 | Drug product | 2025-08-22 | |
| N208418-005 | 10130646 | 2037-07-25 | Drug product | 2025-08-22 |
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 | N208418-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208418-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208418-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208418-004 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2021-06-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208418-005 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2021-06-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208418-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208418-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208418-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208418-004 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2021-06-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208418-005 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2021-06-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208418-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208418-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208418-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208418-004 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2021-06-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208418-005 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2021-06-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208418-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208418-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208418-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208418-004 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-06-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208418-005 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-06-17 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208418-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208418-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208418-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208418-004 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-06-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208418-005 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-06-17 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208418-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208418-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208418-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208418-004 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-06-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208418-005 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-06-17 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208418-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208418-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208418-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208418-004 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-06-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208418-005 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-06-17 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208418-001 | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208418-002 | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208418-003 | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2017-06-15 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208418-004 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 1GM/50ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-06-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208418-005 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | 2GM/100ML (20MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-06-17 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N208418-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208418-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208418-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N208418-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208418-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208418-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208418-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208418-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208418-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N208418-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208418-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208418-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208418-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208418-005 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208418-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208418-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208418-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208418-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208418-005 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208418-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208418-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208418-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208418-004 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208418-005 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208418-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208418-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208418-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208418-004 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208418-005 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208418-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208418-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208418-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208418-004 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208418-005 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208418-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208418-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208418-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208418-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208418-005 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208418-001 | AP | 1 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N208418-004 | 10130646 | 2037-07-25 | Drug product | 2025-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208418-005 | 10130646 | 2037-07-25 | Drug product | 2025-08-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208418-004 | 10130646 | 2037-07-25 | Drug product | 2025-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208418-005 | 10130646 | 2037-07-25 | Drug product | 2025-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208418-004 | 10130646 | 2037-07-25 | Drug product | 2025-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208418-005 | 10130646 | 2037-07-25 | Drug product | 2025-08-22 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N208418-004 | 10130646 | 2037-07-25 | Drug product | 2025-08-22 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N208418-005 | 10130646 | 2037-07-25 | Drug product | 2025-08-22 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Calcium Gluconate | CALCIUM GLUCONATE | Fresenius Kabi USA, LLC | 8b77c3d2-992d-4261-8421-9cfd07328fbf | 2026-05-18 | Warnings, Adverse reactions | 208418 NDA208418 |
| Calcium Gluconate | CALCIUM GLUCONATE | Henry Schein, Inc. | 841ea51f-dc0d-45ed-8b55-bb64640cb930 | 2025-11-03 | Warnings, Adverse reactions | 208418 NDA208418 |
| Calcium Gluconate | CALCIUM GLUCONATE | REMEDYREPACK INC. | 4c635f60-7868-46d5-b932-d5cf8fc84432 | 2025-09-29 | Warnings, Adverse reactions | 208418 NDA208418 |
| Calcium Gluconate | CALCIUM GLUCONATE | ProPharma Distribution | 38413366-b558-7dd0-e063-6394a90acb7e | 2025-07-18 | Warnings, Adverse reactions | 208418 NDA208418 |
| Calcium Gluconate | CALCIUM GLUCONATE | Fresenius Kabi USA, LLC | 1aaf5c76-e526-4d8b-887e-cc3c4f39cc8b | 2024-08-21 | Warnings, Adverse reactions | 208418 NDA208418 |
| Calcium Gluconate | CALCIUM GLUCONATE | Fresenius Kabi USA, LLC | 7f5101e0-abf9-4fcf-8986-c799e3333434 | 2024-05-06 | Warnings, Adverse reactions | 208418 NDA208418 |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | HF Acquisition Co LLC, DBA HealthFirst | 788ab6d7-d80c-0220-e053-2991aa0ae6e9 | 2024-02-01 | Warnings, Adverse reactions | 208418 NDA208418 |
| Calcium Gluconate | CALCIUM GLUCONATE | Medical Purchasing Solutions, LLC | b6226367-b061-eec5-e053-2a95a90a617d | 2023-05-04 | Warnings, Adverse reactions | 208418 NDA208418 |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | HF Acquisition Co LLC, DBA HealthFirst | 7d93251a-b555-0be0-e053-2991aa0ad764 | 2022-12-10 | Warnings, Adverse reactions | 208418 NDA208418 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52584-360-03 | 52584036003 | 1 VIAL, PLASTIC in 1 BAG (52584-360-03) > 50 mL in 1 VIAL, PLASTIC | 2018-02-12 | 2024-03-31 | No | No | Current |