Calcium Gluconate
- Product NDC
- 50090-3398
- 11-digit product format
- 500903398
- Labeler code
- 50090
- Product ID
- 50090-3398_986ef76b-51ee-4ea6-aa6b-55abb5d1af24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcium Gluconate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- A-S Medication Solutions
- Application
- NDA208418
- Marketing category
- NDA
- Marketing start
- 2017-06-15
- Marketing end
- 0000-00-00
- Substance
- CALCIUM GLUCONATE MONOHYDRATE
- Active strength
- 98 mg/mL
- Pharmacologic classes
- Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 product | product | 50090-3398 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 50090-3398 | 50090-3398-0 | I | Inactivated by FDA | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-3398-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-3398-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-3398-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-3398-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-3398-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-3398-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-3398-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-3398-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-3398-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-3398-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-3398-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-3398-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-3398-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-3398-0 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-3398-0 | 1332a3947898… | d4bfe170f9cd… |
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… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bee4fa8d-8d82-423a-a0b5-40a89dd13a99 | Product name | 1 | 20250618 |
| e0d2eb29-08bd-4bba-90d1-c91c68a38767 | Product name | 4 | 20250516 |
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 334fe8d2-68fb-4331-a576-420e302ec069 | Product name | 7 | 20240320 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| e92765c1-be81-432a-b909-1b10777ec378 | Product name | 1 | 20190208 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 0441a8f5-3835-497c-aedd-bc78cba56b2a | Product name | 1 | 20150317 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-3398-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-e4ea-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CALCIUM GLUCONATE INJECTION safely and effectively. See full prescribing information for CALCIUM GLUCONATE INJECTION. CALCIUM GLUCONATE injection, for intravenous use Initial U.S. Approval: 1941 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-3398-0 | Calcium Gluconate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 1 | |
| 50090-3398-0 | Calcium Gluconate | 10 mL in 1 VIAL, PLASTIC | INJECTION, SOLUTION | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-3398-0 | ML - Milliliter | 50090-3398 | e4b6d4ba-2cdf-4666-a2ea-baec2d1f2d12 | 1 | 2019-05-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3398 | CALCIUM GLUCONATE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20190205_d98cdf54-0dce-459f-881f-3b6c6e6185fe.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 |
|---|---|---|---|---|---|---|
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1668250 | calcium gluconate 1 GM in 10 ML (10 % ) Injection | PSN | d98cdf54-0dce-459f-881f-3b6c6e6185fe | 1 |
| 1668250 | 10 ML calcium gluconate 100 MG/ML Injection | SCD | d98cdf54-0dce-459f-881f-3b6c6e6185fe | 1 |
| 1668250 | calcium gluconate 10 % per 10 ML Injection | SY | d98cdf54-0dce-459f-881f-3b6c6e6185fe | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-3398-0 | 50090339800 | 25 VIAL, PLASTIC in 1 TRAY (50090-3398-0) > 10 mL in 1 VIAL, PLASTIC | 2018-03-14 | 0000-00-00 | No | No | Current |